Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-24 @ 10:50 AM
Study NCT ID:
NCT02431468
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2015-04-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Assessing Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C046785', 'term': 'bryostatin 1'}, {'id': 'D054713', 'term': 'Bryostatins'}], 'ancestors': [{'id': 'D000095702', 'term': 'Polyether Toxins'}, {'id': 'D000095662', 'term': 'Polyether Polyketides'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008387', 'term': 'Marine Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dcrockford@neurotropebioscience.com', 'phone': '(973)242-0005', 'title': 'David Crockford, Vice President, Regulatory Affairs', 'organization': 'Neurotrope BioScience, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected beginning at the time of informed consent until the 30-day post treatment visit. For subjects enrolled under protocol versions 1 (17 Apr 2015) and 2 (20 Jan 2016), this collection occurred from Day -21 through Day 198 for subjects completing the study. For subjects enrolled under protocol version 3 (15 Jul 2016) this collection occurred from Day -28 through Day 105.', 'description': 'In addition to the standard defined adverse events, an adverse event of special interest was defined in this study; myalgia.', 'eventGroups': [{'id': 'EG000', 'title': 'Bryostatin 1 20ug', 'description': 'Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 21, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Bryostatin 1 40ug', 'description': 'Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 46, 'seriousNumAtRisk': 47, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.\n\nPlacebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 12, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Dementia Alzheimer's Type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety: Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bryostatin 1 20ug', 'description': 'Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'OG001', 'title': 'Bryostatin 1 40ug', 'description': 'Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.\n\nPlacebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.'}], 'classes': [{'title': 'Number of Subjects w Treatment Emergent AE (TEAE)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': '# of Subjects w Treatment Related TEAE', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': '# of Subjects w TEAE leading to treatment discont.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '# of Subjects with Serious TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': '# of Subjects with Treatment Related Serious TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '# of Subjects w Treatment Emergent Myalgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '# of Subjects w Serious Treatment Emergent Myalgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '# of Subjects with Fatal TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 30 days post end of treatment (up to Day 107)', 'description': 'Evaluations of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'Efficacy: Change From Baseline in Severe Impairment Battery (SIB) in the Full Analysis Set (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bryostatin 1 20ug', 'description': 'Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'OG001', 'title': 'Bryostatin 1 40ug', 'description': 'Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.\n\nPlacebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.'}], 'classes': [{'title': 'Week 13 Full Analysis Set (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '7.10', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '6.58', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '9.02', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 Completer Analysis Set (CAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '7.10', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '6.58', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '9.02', 'groupId': 'OG002'}]}]}, {'title': '30-Day Followup Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '8.17', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '7.51', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '11.44', 'groupId': 'OG002'}]}]}, {'title': '30-Day Followup Completer Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '8.17', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '7.85', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '11.44', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.1', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.5', 'pValueComment': 'LSM and two-sided 80% CI were provided for treatment group differences and estimated endpoint values. A true mean difference in change from baseline in the SIB (one-sided at α=0.10) of at least 6.5 points in favor of bryostatin groups was assumed.', 'groupDescription': 'The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the Severe Impairment Battery (SIB) after 12 weeks of treatment. A linear model was used for both estimation and significance testing. Primary analysis populations were defined as the Full Analysis Set (FAS) and the Completer Analysis Set (CAS)', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.1', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.5', 'groupDescription': 'Change from baseline in SIB in the Completer Analysis Set (CAS)', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Primary analysis at Week 13 (day 91) after 12 weeks of treatment (up to day 107)', 'description': 'The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the total SIB score after 12 weeks of treatment, assessed at Week 13 (day 91). Efficacy analyses were conducted according to randomized groups. The SIB is used to assess cognition in subjects with moderate and severe AD. It is divided into nine subscales that include attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a point score range of 0-100. Lower scores indicate greater cognitive impairment.', 'unitOfMeasure': 'mean change from baseline in SIB score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS), consistent with a modified intention-to-treat principle (mITT), was defined as all randomized subjects who received at least one dose of randomized trial medication and who had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Secondary Efficacy Endpoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bryostatin 1 20ug', 'description': 'Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'OG001', 'title': 'Bryostatin 1 40ug', 'description': 'Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.\n\nPlacebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.'}], 'classes': [{'title': 'SIB Week 5 Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '7.36', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '6.55', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '10.31', 'groupId': 'OG002'}]}]}, {'title': 'SIB Week 5 Completer Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '6.02', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '5.93', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '10.33', 'groupId': 'OG002'}]}]}, {'title': 'SIB Week 9 Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '6.87', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '6.41', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '9.91', 'groupId': 'OG002'}]}]}, {'title': 'SIB Week 9 Completer Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '6.93', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '6.06', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '10.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 5 ADCS-ADL-SIV : FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '4.16', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '6.31', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '5.07', 'groupId': 'OG002'}]}]}, {'title': 'Week 9 ADCS-ADL-SIV : FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '5.05', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '4.07', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 ADCS-ADL-SIV : FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '4.59', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '4.86', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '5.28', 'groupId': 'OG002'}]}]}, {'title': 'Week 5 MMSE-2: FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.79', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '2.40', 'groupId': 'OG002'}]}]}, {'title': 'Week 9 MMSE-2: FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '3.01', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '3.11', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 MMSE-2: FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.54', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '3.49', 'groupId': 'OG002'}]}]}, {'title': 'Week 5 Neuropsychiatric Inventory (NPI): FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '11.72', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '12.03', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '10.31', 'groupId': 'OG002'}]}]}, {'title': 'Week 9 Neuropsychiatric Inventory (NPI): FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '11.97', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '8.33', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '11.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 13 Neuropsychiatric Inventory (NPI): FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '12.62', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '11.94', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '10.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 5, Week 9, Week 13', 'description': '* Change from baseline in the Severe Impairment Battery (SIB) at Weeks 5 and 9. Assesses cognition. Score range 0-100. Lower scores indicate greater cognitive impairment.\n* Change from baseline in Alzheimer Disease Cooperative Study Activities of Daily Living Inventory-Severe Impairment Version (ADCS-ADL-SEV) at Weeks 5, 9,13. A 19-item test of the performance of activities of daily living. Total score range 0-54; lower scores indicate greater functional impairment.\n* Change from baseline in MMSE-2 at Weeks 5, 9 and 13. Tests selected aspects of cognition on a scale of 0-30. Lower scores indicate greater cognitive impairment.\n* Change from baseline in Neuropsychiatric Inventory (NPI) at Weeks 5, 9,13. Caregiver interview assesses 12 behavioral disturbances. Scores range from 0-144; higher scores indicate greater behavioral disturbances.\n* Clinical Global Impression of Improvement (CGI-I) at Weeks 5, 9, 13. A 7-point scale range from (1) very much improved to (7) very much worse.', 'unitOfMeasure': 'mean change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed over the course of the study diminished as a result of attrition.'}, {'type': 'POST_HOC', 'title': 'Severe Impairment Battery (SIB) Scores by Memantine Use at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Bryostatin 1 20ug With Memantine', 'description': 'Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'OG001', 'title': 'Bryostatin 1 40ug With Memantine', 'description': 'Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'OG002', 'title': 'Placebo With Memantine', 'description': 'Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.\n\nPlacebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.'}, {'id': 'OG003', 'title': 'Bryostatin 1 20ug Without Memantine', 'description': 'Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.'}, {'id': 'OG004', 'title': 'Bryostatin 1 40ug Without Memantine', 'description': 'Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.'}, {'id': 'OG005', 'title': 'Placebo Without Memantine', 'description': 'Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.'}], 'classes': [{'title': 'Week 5 SIB change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '8.11', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '6.50', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '10.50', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '5.75', 'groupId': 'OG003'}, {'value': '3.9', 'spread': '4.98', 'groupId': 'OG004'}, {'value': '-1.2', 'spread': '10.26', 'groupId': 'OG005'}]}]}, {'title': 'Week 9 SIB change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '6.52', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '6.88', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '11.01', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '7.04', 'groupId': 'OG003'}, {'value': '2.0', 'spread': '3.16', 'groupId': 'OG004'}, {'value': '0.8', 'spread': '7.44', 'groupId': 'OG005'}]}]}, {'title': 'Week 13 SIB change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '6.51', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '6.61', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '10.03', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '7.01', 'groupId': 'OG003'}, {'value': '3.9', 'spread': '5.84', 'groupId': 'OG004'}, {'value': '-1.1', 'spread': '6.89', 'groupId': 'OG005'}]}]}, {'title': '30-day Followup SIB change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '8.39', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '7.71', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '13.10', 'groupId': 'OG002'}, {'value': '6.7', 'spread': '5.58', 'groupId': 'OG003'}, {'value': '4.0', 'spread': '5.66', 'groupId': 'OG004'}, {'value': '-1.0', 'spread': '8.31', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessments at weeks 5, 9, 13, and 30 days after end of treatment (up to day 107).', 'description': 'Change from baseline in SIB score was compared between subjects receiving concurrent treatment with memantine and subjects not being treated with memantine.', 'unitOfMeasure': 'mean change from baseline in SIB score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the 3 treatment groups were further sorted by use of memantine. The number of participants in each category at each timepoint is noted. Attrition occurred through the course of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bryostatin 1 20ug', 'description': 'Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'FG001', 'title': 'Bryostatin 1 40ug', 'description': 'Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.\n\nPlacebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Safety Analysis set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'noncompliance, investigator termination,', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Planned: 250 subjects to be screened for a total of 140 subjects randomized 1:1:1 to one of three treatment arms: 20μg, 40μg or placebo Actual: 264 subjects were screened. 147 individual subjects were randomized and of those, 141 were dosed with trial drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Bryostatin 1 20ug', 'description': 'Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'BG001', 'title': 'Bryostatin 1 40ug', 'description': 'Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.\n\nBryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.\n\nPlacebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'spread': '8.40', 'groupId': 'BG000'}, {'value': '70.2', 'spread': '7.53', 'groupId': 'BG001'}, {'value': '73.5', 'spread': '7.68', 'groupId': 'BG002'}, {'value': '71.7', 'spread': '7.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Mini Mental State Exam-version 2 (MMSE-2) baseline scores 4-9', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ion, language, and praxis on a scale of 0-30. Lower scores indicate greater cognitive impairment. For this study, subjects were stratified at randomization based on Mini Mental State Exam version 2 (MMSE-2) scores 4-9 (severe cognitive impairment) and 10-15 (moderately severe impairment).', 'unitOfMeasure': 'Participants'}, {'title': 'Mini Mental State Exam version 2 (MMSE-2) baseline score 10-15', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'For this study, subjects were stratified at randomization by Mini Mental State Exam version 2 (MMSE-2) scores 4-9 (severe cognitive impairment) and 10-15 (moderately severe impairment)', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-03', 'size': 1421377, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-26T16:11', 'hasProtocol': True}, {'date': '2017-03-17', 'size': 687515, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-30T14:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-06', 'studyFirstSubmitDate': '2015-04-22', 'resultsFirstSubmitDate': '2018-04-30', 'studyFirstSubmitQcDate': '2015-04-27', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-06', 'studyFirstPostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events', 'timeFrame': 'Baseline through 30 days post end of treatment (up to Day 107)', 'description': 'Evaluations of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia'}, {'measure': 'Efficacy: Change From Baseline in Severe Impairment Battery (SIB) in the Full Analysis Set (FAS)', 'timeFrame': 'Primary analysis at Week 13 (day 91) after 12 weeks of treatment (up to day 107)', 'description': 'The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the total SIB score after 12 weeks of treatment, assessed at Week 13 (day 91). Efficacy analyses were conducted according to randomized groups. The SIB is used to assess cognition in subjects with moderate and severe AD. It is divided into nine subscales that include attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a point score range of 0-100. Lower scores indicate greater cognitive impairment.'}], 'secondaryOutcomes': [{'measure': 'Secondary Efficacy Endpoints', 'timeFrame': 'Week 5, Week 9, Week 13', 'description': '* Change from baseline in the Severe Impairment Battery (SIB) at Weeks 5 and 9. Assesses cognition. Score range 0-100. Lower scores indicate greater cognitive impairment.\n* Change from baseline in Alzheimer Disease Cooperative Study Activities of Daily Living Inventory-Severe Impairment Version (ADCS-ADL-SEV) at Weeks 5, 9,13. A 19-item test of the performance of activities of daily living. Total score range 0-54; lower scores indicate greater functional impairment.\n* Change from baseline in MMSE-2 at Weeks 5, 9 and 13. Tests selected aspects of cognition on a scale of 0-30. Lower scores indicate greater cognitive impairment.\n* Change from baseline in Neuropsychiatric Inventory (NPI) at Weeks 5, 9,13. Caregiver interview assesses 12 behavioral disturbances. Scores range from 0-144; higher scores indicate greater behavioral disturbances.\n* Clinical Global Impression of Improvement (CGI-I) at Weeks 5, 9, 13. A 7-point scale range from (1) very much improved to (7) very much worse.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "This is a randomized double-blind placebo-controlled study comparing different doses of bryostatin for the treatment of moderately severe to severe Alzheimer's disease. The study is 15 weeks in duration, including a safety and efficacy evaluation 30 days after the last dose of study drug.", 'detailedDescription': "This study will enroll 150 moderately severe to severe Alzheimer's disease subjects. Subjects will be randomly assigned 1:1:1 to treatment with two different doses of bryostatin 1 or placebo. The primary analysis will take place after 12 weeks of treatment (7 doses)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent from caregiver and subject (if possible) or legally acceptable representative if different from caregiver\n* Male and female subjects 55-85 years of age inclusive\n* Cognitive deficit present for at least 2 years that meet the diagnostic criteria for probable Alzheimer's\n* Mini Mental State Exam (MMSE-2) score of 4-15\n* Patients must be able to perform at least one item on the Severe Impairment Battery Scale\n* Neuroimaging (computerized tomography (CT) or Magnetic Resonance Imaging (MRI)) within the last 24 months consistent with a diagnosis of probable Alzheimer's disease (AD)\n* Reliable caregiver(s) or informant(s) who attends the subject at least an average of 3 hours or more per day for 3 or more days per week\n* Adequate vision and motor function to comply with testing\n* If taking drugs approved for treatment of Alzheimer's disease (e.g. cholinesterase inhibitors, memantine), must be on a stable dose for at least 3 months prior to entry into study and the dose must not change during the study unless a change is required due to an adverse event or a clinically significant change in the patient's status.\n\nExclusion Criteria:\n\n* Dementia due to any condition other than AD, including vascular dementia (Rosen-modified Hachinski lschemic score ≥ 5)\n* Evidence of significant central nervous system (CNS) vascular disease on previous neuroimaging including but not limited to: cortical stroke, multiple infarcts, localized single infarcts in the thalamus, angular gyrus, multiple lacunar infarcts or extensive white matter injury\n* Clinically significant neurologic disease or condition other than AD, such as cerebral tumor, chronic subdural fluid collections, Huntington's Disease, Parkinson's Disease, normal pressure hydrocephalus, or any other diagnosis that could interfere with assessment of safety and efficacy\n* Evidence of clinically significant unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurologic, or metabolic disease within the 6 months prior to enrollment\n* Poorly controlled diabetes, at the discretion of the Principal Investigator\n* Creatinine clearance (CL) of \\<45ml/min\n* Use of an active Alzheimer's vaccine within 2 years prior to screening\n* Use of a monoclonal antibody for treatment of AD within 1 year prior to screening\n* Any medical or psychiatric condition that is likely to require initiation of additional medication or surgical intervention during the course of the study\n* Use of an investigational drug within 30 days prior to screening\n* Prior exposure to bryostatin, or known sensitivity to bryostatin or any ingredient in the study drug\n* Any other concurrent medical condition, which in the opinion of the PI makes the subject unsuitable for the clinical study"}, 'identificationModule': {'nctId': 'NCT02431468', 'briefTitle': "A Study Assessing Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurotrope Bioscience, Inc.'}, 'officialTitle': "A Randomized, Double-Blind,Placebo-Controlled, Phase 2 Study Assessing the Safety, Tolerability and Efficacy of Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'NTRP-101-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bryostatin 1 20ug', 'description': 'Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.', 'interventionNames': ['Drug: Bryostatin 1']}, {'type': 'EXPERIMENTAL', 'label': 'Bryostatin 1 40ug', 'description': 'Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.', 'interventionNames': ['Drug: Bryostatin 1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Bryostatin 1', 'type': 'DRUG', 'otherNames': ['bryostatin'], 'description': 'The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.', 'armGroupLabels': ['Bryostatin 1 20ug', 'Bryostatin 1 40ug']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Xenoscience, Inc/ 21st Century Neurology', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'ATP Clinical Research, Inc.', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Nader Pharmacology Research Institute', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Clinical Research Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'JEM Research', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Brain Matters Research', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Neuropsychiatric Research Center of South Florida', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33449', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': "Alzheimer's Research and Treatment Center", 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Jewish Health System', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Medical Research Group of Central Florida', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Axiom Clinical Research of Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32162', 'city': 'The Villages', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research', 'geoPoint': {'lat': 28.93408, 'lon': -81.95994}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'iResearch Atlanta', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Neurosciences Institute Clinical Research', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'country': 'United States', 'facility': "University of Kansas Alzheimer's Disease Center", 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '70629', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Lake Charles Clinical Trials', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '71104', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'J. Gary Booker, MD APMC Clinical Drug Trials', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', 'country': 'United States', 'facility': 'Millennium Psychiatric Associates', 'geoPoint': {'lat': 38.66089, 'lon': -90.42262}}, {'zip': '07801', 'city': 'Springfield', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Neuroscience Institute', 'geoPoint': {'lat': 40.70491, 'lon': -74.31723}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Neurological Associates of Albany, PC', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Parker Jewish Institute for Health Care and Rehabilitation', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '28270', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': "Alzheimer's Memory Center", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurobehavioral Clinical Research', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Clinical Research Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Sunstone Clinical Research', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'city': 'Jenkintown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Clinical Trial Center, LLC', 'geoPoint': {'lat': 40.09594, 'lon': -75.12517}}, {'zip': '38018', 'city': 'Cordova', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Neurology Clinic, PC', 'geoPoint': {'lat': 35.15565, 'lon': -89.7762}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurotrope Bioscience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}