Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
Study NCT ID:
NCT02918266
Status:
TERMINATED
Last Update Posted:
2019-06-14
First Post:
2016-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
TAK-071 Scopolamine-Induced Cognitive Impairment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012601', 'term': 'Scopolamine'}, {'id': 'C000723104', 'term': 'TAK-071'}, {'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug up to Day 12 in Part 1 and Day 9 of Period 1 in Part 2 (study termination) after the last dose of study drug', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 milligram (mg), drug in capsule (DIC), orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously (SC), on Day 2.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 2: Change From Baseline in Total Number of Errors on the Groton Maze Learning Test (GMLT) at 2 Hours Post-Scopolamine Dose on Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG001', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'timeFrame': 'Baseline, 2 hours post scopolamine dose on Day 2', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for Part 2 due to premature study termination because of indication change.'}, {'type': 'SECONDARY', 'title': 'Part 2: Change From Baseline in Total Number of Errors on the GMLT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG001', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'timeFrame': 'Baseline, Day 2 at multiple time points post-scopolamine dose (up to 10 hours)', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for Part 2 due to premature study termination because of indication change.'}, {'type': 'SECONDARY', 'title': 'Part 2: AUECt: GMLT Area Under the Effect Curve From Time 0 Hours to Time t (AUECt) (Net Area) for TAK-071', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG001', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'timeFrame': 'Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for Part 2 due to premature study termination because of indication change.'}, {'type': 'SECONDARY', 'title': 'Part 2: Emax: GMLT Maximum Observed Effect (Emax) for TAK-071', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG001', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'timeFrame': 'Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for Part 2 due to premature study termination because of indication change.'}, {'type': 'SECONDARY', 'title': 'Part 2: TEmax: Time to Reach GMLT Emax for TAK-071', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG001', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'timeFrame': 'Day 2 pre-dose and at multiple timepoints (up to 10 hours) post-scopolamine dose', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for Part 2 due to premature study termination because of indication change.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Scopolamine 0.5 mg SC + TAK-071 80 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'OG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who were enrolled and received 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Scopolamine 0.5 mg SC + TAK-071 80 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'OG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who were enrolled and received 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'OG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'classes': [{'title': 'Diastolic Blood Pressure (mmHg)/Supine <50 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Pulse rate/supine: <50 beats per minute', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}]}]}, {'title': 'Temperature: <35.6 Celsius', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Temperature: >37.7 Celsius', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who were enrolled and received 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Electrocardiogram (ECG) at Least Once Postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'OG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who were enrolled and received 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for TAK-071', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'OG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1066', 'spread': '16.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time to Reach the Maximum Observed Plasma Concentration(Cmax) for TAK-071', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'OG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.00', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '34.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change.'}, {'type': 'SECONDARY', 'title': 'AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-071', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'OG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '82010', 'spread': '25.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose', 'unitOfMeasure': 'hour*nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.No data was collected for Part 2 due to premature study termination because of indication change.'}, {'type': 'SECONDARY', 'title': 'AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for TAK-071', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'OG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '19330', 'spread': '16.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-scopolamine dose', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change.'}, {'type': 'SECONDARY', 'title': 'AUCt1-t2: Area Under the Plasma Concentration-Time Curve From Time t1 to Time t2 for TAK-071', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'OG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose', 'reportingStatus': 'POSTED', 'populationDescription': 'As per change in planned analyses, data was not collected.'}, {'type': 'SECONDARY', 'title': 'AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'OG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '94100', 'spread': '26.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change.'}, {'type': 'SECONDARY', 'title': 'T1/2z: Terminal Disposition Phase Elimination Half-Life in Plasma for TAK-071', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'OG001', 'title': 'Part 2: Treatment A', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG002', 'title': 'Part 2: Treatment B', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG003', 'title': 'Part 2: Treatment C', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG004', 'title': 'Part 2: Treatment D', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}, {'id': 'OG005', 'title': 'Part 2: Treatment E', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.02', 'spread': '14.864', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 milligram (mg), drug in capsule (DIC), orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously (SC), on Day 2.'}, {'id': 'FG001', 'title': 'Part 2: Treatment Sequence ABDEC', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'FG002', 'title': 'Part 2: Treatment Sequence BCEAD', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'FG003', 'title': 'Part 2: Treatment Sequence CDABE', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period'}, {'id': 'FG004', 'title': 'Part 2: Treatment Sequence DEBCA', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'FG005', 'title': 'Part 2: Treatment Sequence EACDB', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'FG006', 'title': 'Part 2: Treatment Sequence ACBED', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'FG007', 'title': 'Part 2: Treatment Sequence BDCAE', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B);followed by TAK-071 80 mg, DIC, orally, Day1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C);followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'FG008', 'title': 'Part 2: Treatment Sequence CEDBA', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'FG009', 'title': 'Part 2: Treatment Sequence DAECB', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'FG010', 'title': 'Part 2: Treatment Sequence EBADC', 'description': 'TAK-071 80 mg, placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period.'}], 'periods': [{'title': 'Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Intervention Period 1 (2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}]}]}, {'title': 'Part 2: Washout Period 1 (3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Intervention Period 2 (2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Washout Period 2 (3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Intervention Period 3 (2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Washout Period 3 (3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Intervention Period 4 (2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Washout Period 4 (3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Intervention Period 5 (2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 1 investigative site in the United states from 21 November 2016 to 08 August 2017.', 'preAssignmentDetails': 'Healthy male participants were enrolled in this 2-part study to receive: TAK-071, scopolamine in Part 1; TAK-071, scopolamine and donepezil in a cross-over sequence in Part 2. The study was terminated prior to start of Part 2 intervention period 2 due to indication change.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '18', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, followed by scopolamine 0.5 mg, injection, SC, on Day 2. TAK-071 will be taken 24 hours before scopolamine injection.'}, {'id': 'BG001', 'title': 'Part 2: Treatment Sequence ABDEC', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'BG002', 'title': 'Part 2: Treatment Sequence BCEAD', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'BG003', 'title': 'Part 2: Treatment Sequence CDABE', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period'}, {'id': 'BG004', 'title': 'Part 2: Treatment Sequence DEBCA', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'BG005', 'title': 'Part 2: Treatment Sequence EACDB', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'BG006', 'title': 'Part 2: Treatment Sequence ACBED', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 1 (A); followed by TAK-071 DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (D). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'BG007', 'title': 'Part 2: Treatment Sequence BDCAE', 'description': 'TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (B);followed by TAK-071 80 mg, DIC, orally, Day1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (D);followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (C);followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 4 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (E). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'BG008', 'title': 'Part 2: Treatment Sequence CEDBA', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, Day 2 of Period 4 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 5 (A). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'BG009', 'title': 'Part 2: Treatment Sequence DAECB', 'description': 'TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (D); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 2 (A); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 3 (E); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (C); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (B). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'BG010', 'title': 'Part 2: Treatment Sequence EBADC', 'description': 'TAK-071 80 mg, placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 1 (E); followed by TAK-071 placebo-matching DIC, orally, Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 2 (B); followed by TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 of Period 3 (A); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 4 (D); followed by TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 of Period 5 (C). A washout period of 3-weeks was maintained between each treatment period.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '18', 'groupId': 'BG011'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '18', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '18', 'groupId': 'BG011'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Classification', 'classes': [{'title': 'Never smoked', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '16', 'groupId': 'BG011'}]}]}, {'title': 'Current smoker', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol Classification', 'classes': [{'title': 'Never drunk', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}]}]}, {'title': 'Current drinker: had less than (<) 4 units per day', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}]}]}, {'title': 'Current drinker: had 4 or more units per day', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}, {'title': 'Ex-drinker', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Caffeine Consumption', 'classes': [{'title': 'Had caffeine consumption', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}]}]}, {'title': 'Had no caffeine consumption', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '13', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Academic Qualifications', 'classes': [{'title': 'No degree or diploma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}, {'title': 'Elementary school', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}, {'title': 'High school', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}]}]}, {'title': 'Non university degree', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}]}, {'title': 'University', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '11', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety analysis set included all participants who were enrolled and received 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-10', 'size': 1175571, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-01T14:24', 'hasProtocol': True}, {'date': '2018-03-22', 'size': 2475367, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-01T14:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Terminated prematurely due to indication change.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-11-21'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-15', 'studyFirstSubmitDate': '2016-09-27', 'resultsFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-15', 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 2: Change From Baseline in Total Number of Errors on the Groton Maze Learning Test (GMLT) at 2 Hours Post-Scopolamine Dose on Day 2', 'timeFrame': 'Baseline, 2 hours post scopolamine dose on Day 2'}], 'secondaryOutcomes': [{'measure': 'Part 2: Change From Baseline in Total Number of Errors on the GMLT', 'timeFrame': 'Baseline, Day 2 at multiple time points post-scopolamine dose (up to 10 hours)'}, {'measure': 'Part 2: AUECt: GMLT Area Under the Effect Curve From Time 0 Hours to Time t (AUECt) (Net Area) for TAK-071', 'timeFrame': 'Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose'}, {'measure': 'Part 2: Emax: GMLT Maximum Observed Effect (Emax) for TAK-071', 'timeFrame': 'Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose'}, {'measure': 'Part 2: TEmax: Time to Reach GMLT Emax for TAK-071', 'timeFrame': 'Day 2 pre-dose and at multiple timepoints (up to 10 hours) post-scopolamine dose'}, {'measure': 'Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1'}, {'measure': 'Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Postdose', 'timeFrame': 'Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1'}, {'measure': 'Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose', 'timeFrame': 'Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1'}, {'measure': 'Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Electrocardiogram (ECG) at Least Once Postdose', 'timeFrame': 'Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1'}, {'measure': 'Cmax: Maximum Observed Plasma Concentration for TAK-071', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose'}, {'measure': 'Tmax: Time to Reach the Maximum Observed Plasma Concentration(Cmax) for TAK-071', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose'}, {'measure': 'AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-071', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose'}, {'measure': 'AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for TAK-071', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-scopolamine dose'}, {'measure': 'AUCt1-t2: Area Under the Plasma Concentration-Time Curve From Time t1 to Time t2 for TAK-071', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose'}, {'measure': 'AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose'}, {'measure': 'T1/2z: Terminal Disposition Phase Elimination Half-Life in Plasma for TAK-071', 'timeFrame': 'Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of a single oral dose of TAK-071 on the attenuation of cognitive deficit induced by scopolamine as measured by Groton Maze Learning Test (GMLT) (total number of errors).', 'detailedDescription': 'The drug being tested in this study is called TAK-071. This study will look at the effect of a single oral dose of TAK-071, a novel muscarinic acetylcholine receptor 1 positive allosteric modulator, on scopolamine-induced deficits in cognitive function in healthy adult male participants. The study consists of two parts: Part 1 is a substudy to explore PK profile of TAK-071 in the presence of light meal and coadministration of scopolamine to determine TAK-071 dose for the next part; Part 2 is the main the study to assess the effects of TAK-071 on scopolamine-induced cognitive impairment. The study will enroll approximately 6 participants in Part 1 and 40 participants in Part 2. Participant will be assigned to received TAK-071 along with scopolamine in Part 1 and will be randomly assigned to one of the ten treatment sequences in Part 2-which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):\n\nPart 2: Treatment Sequence ABDEC Part 2: Treatment Sequence BCEAD Part 2: Treatment Sequence CDABE Part 2: Treatment Sequence DEBCA Part 2: Treatment Sequence EACDB Part 2: Treatment Sequence ACBED Part 2: Treatment Sequence BDCAE Part 2: Treatment Sequence CEDBA Part 2: Treatment Sequence DAECB Part 2: Treatment Sequence EBADC Where A=scopolamine matching placebo SC + TAK-071 matching placebo oral (PO) + donepezil matching placebo PO; B=scopolamine 0.5 mg SC + TAK-071 matching placebo PO + donepezil matching placebo PO; C=scopolamine 0.5 mg SC + TAK-071 PO + donepezil matching placebo PO; D=scopolamine 0.5 mg SC + TAK-071 PO + donepezil 10 mg PO; and E=scopolamine 0.5 mg SC + TAK-071 matching placebo PO + donepezil 10 mg PO.\n\nThe dose of TAK-071 that was well-tolerated in the TAK-071-1001 study (NCT02769065) will be selected, based on the safety and tolerability data from the single-rising dose (SRD) study for administration in Part 1. Each participant will also receive scopolamine 0.5 mg, injection, SC, once at the time of Screening. This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 5.7 weeks in Part 1 and 21 weeks in Part 2. Participants will remain confined to the clinic for 4 days during Part 1 and 3 days during the each intervention period in Part 2. Participants will be contacted by telephone on Day 12 in Part 1 and Day 9 of Period 5 in Part 2 for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m\\^2), inclusive at Screening.\n\nAdditional inclusion criteria for Part 2:\n\n1. Able to perform the CogState battery.\n2. Change from Baseline (average) in total GMLT errors of less than or equal to (\\<=) -5 at 2 hours postdose of scopolamine.\n3. Sleepiness score less than (\\<) 8 on the karolinska sleepiness scale (KSS) at 2 hours postdose of scopolamine.\n4. Passes a hearing test with at least 80 percent (%) correct responses and no more than 20% false positives. This test can be repeated once to determine eligibility.\n\nExclusion Criteria:\n\n1. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular consumption of 4 or more units per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.\n2. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1 of Period 1. Cotinine test is positive at Screening or Check-in (Day -1) of Period 1.\n3. Has poor peripheral venous access.\n4. Has donated or lost 450 milliliter (mL) or more of his blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1 of Period 1.\n5. Is a shift worker (night, late, or early resulting in irregular bed times) or has crossed or will cross more than 2 time zones within 48 hours in the period from 48 hours prior to Treatment Period 1, Day 1 until the end of Treatment Period 5.\n6. Reports symptoms suggesting evidence of a current sleep disorder or history of sleep disorder, including but not limited to sleep apnea, heavy snoring, primary or chronic insomnia, narcolepsy or restless leg syndrome, as judged by medical history.'}, 'identificationModule': {'nctId': 'NCT02918266', 'briefTitle': 'TAK-071 Scopolamine-Induced Cognitive Impairment Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized, Double-Blind, Sponsor Unblinded, Placebo-Controlled, 5-Period Crossover, Phase 1b Study To Evaluate The Effects Of Single Oral Administration of TAK-071 On Scopolamine-Induced Cognitive Impairment In Healthy Subjects', 'orgStudyIdInfo': {'id': 'TAK-071-1002'}, 'secondaryIdInfos': [{'id': 'U1111-1184-2278', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'description': 'TAK-071 80 milligram (mg), drug in capsule (DIC), orally, Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously, Day 2. TAK-071 will be taken 24 hours before scopolamine injection.', 'interventionNames': ['Drug: Scopolamine', 'Drug: TAK-071']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence ABDEC', 'description': 'TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period1(A); followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(B);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(E);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(C). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period.', 'interventionNames': ['Drug: Scopolamine', 'Drug: TAK-071', 'Drug: Donepezil', 'Drug: Scopolamine Placebo', 'Drug: TAK-071 Placebo', 'Drug: Donepezil Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence BCEAD', 'description': 'TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(B);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(C);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(E);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period4(A);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(D). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period.', 'interventionNames': ['Drug: Scopolamine', 'Drug: TAK-071', 'Drug: Donepezil', 'Drug: Scopolamine Placebo', 'Drug: TAK-071 Placebo', 'Drug: Donepezil Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence CDABE', 'description': 'TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(C);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period3(A);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(B);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(E). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period.', 'interventionNames': ['Drug: Scopolamine', 'Drug: TAK-071', 'Drug: Donepezil', 'Drug: Scopolamine Placebo', 'Drug: TAK-071 Placebo', 'Drug: Donepezil Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence DEBCA', 'description': 'TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(E);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(B);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(C);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period5(A). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period.', 'interventionNames': ['Drug: Scopolamine', 'Drug: TAK-071', 'Drug: Donepezil', 'Drug: Scopolamine Placebo', 'Drug: TAK-071 Placebo', 'Drug: Donepezil Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence EACDB', 'description': 'TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(E);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period2(A);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(C);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(B). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period.', 'interventionNames': ['Drug: Scopolamine', 'Drug: TAK-071', 'Drug: Donepezil', 'Drug: Scopolamine Placebo', 'Drug: TAK-071 Placebo', 'Drug: Donepezil Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence ACBED', 'description': 'TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period1(A);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(C);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(B);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(E);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(D). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period.', 'interventionNames': ['Drug: Scopolamine', 'Drug: TAK-071', 'Drug: Donepezil', 'Drug: Scopolamine Placebo', 'Drug: TAK-071 Placebo', 'Drug: Donepezil Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence BDCAE', 'description': 'TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(B);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(D);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(C);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period4(A);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(E). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period.', 'interventionNames': ['Drug: Scopolamine', 'Drug: TAK-071', 'Drug: Donepezil', 'Drug: Scopolamine Placebo', 'Drug: TAK-071 Placebo', 'Drug: Donepezil Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence CEDBA', 'description': 'TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(C);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(E);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(B);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period5(A). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period.', 'interventionNames': ['Drug: Scopolamine', 'Drug: TAK-071', 'Drug: Donepezil', 'Drug: Scopolamine Placebo', 'Drug: TAK-071 Placebo', 'Drug: Donepezil Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence DAECB', 'description': 'TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(D);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period2(A);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period3(E);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(C); followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(B). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period.', 'interventionNames': ['Drug: Scopolamine', 'Drug: TAK-071', 'Drug: Donepezil', 'Drug: Scopolamine Placebo', 'Drug: TAK-071 Placebo', 'Drug: Donepezil Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment Sequence EBADC', 'description': 'TAK-071 placebo-matching DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period1(E);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period2(B);followed by TAK-071 placebo-matching DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection,SC,Day2 of Period3(A);followed by TAK-071 80mg, DIC, orally,Day1, donepezil 10mg, over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period4(D);followed by TAK-071 80mg, DIC, orally,Day1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5mg, injection,SC,Day2 of Period5(C). TAK-071 and donepezil will be taken 24 and 3 hours before scopolamine injection. A washout period of 3-weeks will be maintained between each treatment period.', 'interventionNames': ['Drug: Scopolamine', 'Drug: TAK-071', 'Drug: Donepezil', 'Drug: Scopolamine Placebo', 'Drug: TAK-071 Placebo', 'Drug: Donepezil Placebo']}], 'interventions': [{'name': 'Scopolamine', 'type': 'DRUG', 'description': 'Scopolamine subcutaneous injection', 'armGroupLabels': ['Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'Part 2: Treatment Sequence ABDEC', 'Part 2: Treatment Sequence ACBED', 'Part 2: Treatment Sequence BCEAD', 'Part 2: Treatment Sequence BDCAE', 'Part 2: Treatment Sequence CDABE', 'Part 2: Treatment Sequence CEDBA', 'Part 2: Treatment Sequence DAECB', 'Part 2: Treatment Sequence DEBCA', 'Part 2: Treatment Sequence EACDB', 'Part 2: Treatment Sequence EBADC']}, {'name': 'TAK-071', 'type': 'DRUG', 'description': 'TAK-071 DIC', 'armGroupLabels': ['Part 1: TAK-071 80 mg + Scopolamine 0.5 mg', 'Part 2: Treatment Sequence ABDEC', 'Part 2: Treatment Sequence ACBED', 'Part 2: Treatment Sequence BCEAD', 'Part 2: Treatment Sequence BDCAE', 'Part 2: Treatment Sequence CDABE', 'Part 2: Treatment Sequence CEDBA', 'Part 2: Treatment Sequence DAECB', 'Part 2: Treatment Sequence DEBCA', 'Part 2: Treatment Sequence EACDB', 'Part 2: Treatment Sequence EBADC']}, {'name': 'Donepezil', 'type': 'DRUG', 'description': 'Donepezil over-encapsulated tablet', 'armGroupLabels': ['Part 2: Treatment Sequence ABDEC', 'Part 2: Treatment Sequence ACBED', 'Part 2: Treatment Sequence BCEAD', 'Part 2: Treatment Sequence BDCAE', 'Part 2: Treatment Sequence CDABE', 'Part 2: Treatment Sequence CEDBA', 'Part 2: Treatment Sequence DAECB', 'Part 2: Treatment Sequence DEBCA', 'Part 2: Treatment Sequence EACDB', 'Part 2: Treatment Sequence EBADC']}, {'name': 'Scopolamine Placebo', 'type': 'DRUG', 'description': 'Scopolamine placebo-matching subcutaneous injection', 'armGroupLabels': ['Part 2: Treatment Sequence ABDEC', 'Part 2: Treatment Sequence ACBED', 'Part 2: Treatment Sequence BCEAD', 'Part 2: Treatment Sequence BDCAE', 'Part 2: Treatment Sequence CDABE', 'Part 2: Treatment Sequence CEDBA', 'Part 2: Treatment Sequence DAECB', 'Part 2: Treatment Sequence DEBCA', 'Part 2: Treatment Sequence EACDB', 'Part 2: Treatment Sequence EBADC']}, {'name': 'TAK-071 Placebo', 'type': 'DRUG', 'description': 'TAK-071 placebo-matching DIC', 'armGroupLabels': ['Part 2: Treatment Sequence ABDEC', 'Part 2: Treatment Sequence ACBED', 'Part 2: Treatment Sequence BCEAD', 'Part 2: Treatment Sequence BDCAE', 'Part 2: Treatment Sequence CDABE', 'Part 2: Treatment Sequence CEDBA', 'Part 2: Treatment Sequence DAECB', 'Part 2: Treatment Sequence DEBCA', 'Part 2: Treatment Sequence EACDB', 'Part 2: Treatment Sequence EBADC']}, {'name': 'Donepezil Placebo', 'type': 'DRUG', 'description': 'Donepezil placebo-matching over-encapsulated tablet', 'armGroupLabels': ['Part 2: Treatment Sequence ABDEC', 'Part 2: Treatment Sequence ACBED', 'Part 2: Treatment Sequence BCEAD', 'Part 2: Treatment Sequence BDCAE', 'Part 2: Treatment Sequence CDABE', 'Part 2: Treatment Sequence CEDBA', 'Part 2: Treatment Sequence DAECB', 'Part 2: Treatment Sequence DEBCA', 'Part 2: Treatment Sequence EACDB', 'Part 2: Treatment Sequence EBADC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}