Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 1:52 PM
Study NCT ID:
NCT02167256
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2014-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild 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': 'C515233', 'term': 'saracatinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephen.strittmatter@yale.edu', 'phone': '2037854878', 'title': 'Stephen Strittmatter', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected over a period of 1 year (study duration)', 'eventGroups': [{'id': 'EG000', 'title': 'AZD0530 100mg/125mg Daily', 'description': 'AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily\n\nAZD0530 125mg daily: Patients with plasma drug level \\<100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 73, 'seriousNumAtRisk': 79, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'AZD0530 Placebo', 'description': 'Placebo: 50% of patients will receive placebo treatment for the duration of the study.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 65, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear and labyrinth disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 8}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 22}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0530 100mg/125mg Daily', 'description': 'AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily\n\nAZD0530 125mg daily: Patients with plasma drug level \\<100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530.'}, {'id': 'OG001', 'title': 'AZD0530 Placebo', 'description': 'Placebo: 50% of patients will receive placebo treatment for the duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Composite measure of brain glucose uptake using F18-FDG PET in a pre-defined set of brain regions, between baseline and 12 months.', 'unitOfMeasure': 'umol/100g/min (change)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants is lower than total randomized participants due to a modified intent-to-treat analysis where only randomized participants who also underwent a post-baseline F18-FDG PET brain scan are included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With One or More Serious/Other Adverse Events Subjects With Mild AD as Assessed by Analysis of Adverse Events, Including Symptoms, and Abnormal Findings on Physical and Neurological Examinations, and Standard Labs.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0530 100mg/125mg Daily', 'description': 'AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily\n\nAZD0530 125mg daily: Patients with plasma drug level \\<100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530.'}, {'id': 'OG001', 'title': 'AZD0530 Placebo', 'description': 'Placebo: 50% of patients will receive placebo treatment for the duration of the study.'}], 'classes': [{'title': 'Subjects with one or more adverse events', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with one or more serious adverse events', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Assessment of any adverse effects between drug and placebo-treated subjects', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Effect of Treatment With AZD0530 on Cognitive and Behavioral Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0530 100mg/125mg Daily', 'description': 'AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily\n\nAZD0530 125mg daily: Patients with plasma drug level \\<100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530.'}, {'id': 'OG001', 'title': 'AZD0530 Placebo', 'description': 'Placebo: 50% of patients will receive placebo treatment for the duration of the study.'}], 'classes': [{'title': 'ADAS-Cog score', 'categories': [{'measurements': [{'value': '7.26', 'spread': '0.954', 'groupId': 'OG000'}, {'value': '6.14', 'spread': '0.903', 'groupId': 'OG001'}]}]}, {'title': 'MMSE score', 'categories': [{'measurements': [{'value': '-3.84', 'spread': '0.575', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '0.543', 'groupId': 'OG001'}]}]}, {'title': 'ADCS-ADL', 'categories': [{'measurements': [{'value': '-9.49', 'spread': '1.263', 'groupId': 'OG000'}, {'value': '-7.64', 'spread': '1.199', 'groupId': 'OG001'}]}]}, {'title': 'CDR-SO', 'categories': [{'measurements': [{'value': '1.946', 'spread': '0.292', 'groupId': 'OG000'}, {'value': '1.468', 'spread': '0.274', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The change in cognitive function between baseline and 12 months will be measured by the following tests:\n\n1. Alzheimer Disease Assessment Scale - Cognitive 11 (ADAS-cog11). Measures: Cognitive function Maximum score: 70; Minimum score: 0. Higher score equals worse cognitive function\n2. Mini-Mental State Examination (MMSE) Measures: Cognitive Function Maximum score: 30; Minimum score: 0. Higher score equal better cognitive function\n3. Alzheimer Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Measures: Ability to perform routine daily activities Maximum score: 78; Minimum score: 0. Higher score equals better ability to perform activities of daily living\n4. Clinical Dementia Rating Sum of Boxes (CDR-SO) Measures: Dementia severity Maximum score: 18; Minimum score: 0. Higher score equals more severe dementia.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Brain Volume Before and After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0530 100mg/125mg Daily', 'description': 'AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily\n\nAZD0530 125mg daily: Patients with plasma drug level \\<100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530.'}, {'id': 'OG001', 'title': 'AZD0530 Placebo', 'description': 'Placebo: 50% of patients will receive placebo treatment for the duration of the study.'}], 'classes': [{'title': 'Entorhinal volume change', 'categories': [{'measurements': [{'value': '-2.3939', 'spread': '1.8138', 'groupId': 'OG000'}, {'value': '-3.1002', 'spread': '1.7446', 'groupId': 'OG001'}]}]}, {'title': 'Whole brain volume change', 'categories': [{'measurements': [{'value': '-1.5993', 'spread': '1.0569', 'groupId': 'OG000'}, {'value': '-1.7077', 'spread': '1.0922', 'groupId': 'OG001'}]}]}, {'title': 'Hippocampus volume change', 'categories': [{'measurements': [{'value': '-0.8931', 'spread': '1.8089', 'groupId': 'OG000'}, {'value': '-1.542', 'spread': '1.9893', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Change in volume of pre-defined brain regions between baseline and 12 months of treatment.', 'unitOfMeasure': '% change in volume', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cerebrospinal Fluid Levels of Total Tau, Phospho-tau (p-Tau), and Amyloid-beta 1-42 (Abeta 1-42)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0530 100mg/125mg Daily', 'description': 'AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily\n\nAZD0530 125mg daily: Patients with plasma drug level \\<100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530.'}, {'id': 'OG001', 'title': 'AZD0530 Placebo', 'description': 'Placebo: 50% of patients will receive placebo treatment for the duration of the study.'}], 'classes': [{'title': 'CSF Total tau', 'categories': [{'measurements': [{'value': '91.7448', 'spread': '212.7244', 'groupId': 'OG000'}, {'value': '1.2091', 'spread': '131.2533', 'groupId': 'OG001'}]}]}, {'title': 'CSF p-Tau', 'categories': [{'measurements': [{'value': '1.5837', 'spread': '17.7504', 'groupId': 'OG000'}, {'value': '-1.9986', 'spread': '13.7311', 'groupId': 'OG001'}]}]}, {'title': 'CSF Abeta 1-42', 'categories': [{'measurements': [{'value': '-1.3383', 'spread': '47.3549', 'groupId': 'OG000'}, {'value': '-1.3758', 'spread': '43.3233', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Measure concentration of Tau and Amyloid-beta 1-42 biomarkers in the cerebrospinal fluid between baseline and 12 months of treatment', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants is lower than total randomized participants due to a modified intent-to-treat analysis where only randomized participants who also underwent a post-baseline cerebrospinal fluid analysis were included.'}, {'type': 'SECONDARY', 'title': 'Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0530 100mg/125mg Daily', 'description': 'AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily\n\nAZD0530 125mg daily: Patients with plasma drug level \\<100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530.'}, {'id': 'OG001', 'title': 'AZD0530 Placebo', 'description': 'Placebo: 50% of patients will receive placebo treatment for the duration of the study.'}], 'classes': [{'title': 'APOE4 carrier FDG-PET measure from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'APOE4 non-carrier FDG-PET measure from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The results from the primary outcome with brain FDG-PET imaging was analyzed by ApoE genotype. Composite measure of brain glucose uptake using F18-FDG PET in a pre-defined set of brain regions, between baseline and 12 months.', 'unitOfMeasure': 'umol/100g/min (change)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants is lower than total randomized participants due to a modified intent-to-treat analysis where only randomized participants who also underwent a post-baseline F18-FDG PET brain scan are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD0530 100mg/125mg Daily', 'description': 'AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily\n\nAZD0530 125mg daily: Patients with plasma drug level \\<100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530.'}, {'id': 'FG001', 'title': 'AZD0530 Placebo', 'description': 'Placebo: 50% of patients will receive placebo treatment for the duration of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study partner unable to participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD0530 100mg Daily', 'description': 'Patients in the experimental group (50%) will be started on this dose. After 2 weeks, patients with a plasma drug level of \\<100ng/ml will receive 125mg AZD0530 daily and remain in the same experimental group as patient receiving 100mg daily.\n\nAZD0530 100mg daily: All patients in experimental group (50%) will be started on 100mg AZD0530 daily\n\nAZD0530 125mg daily: Patients with plasma drug level \\<100ng/ml after 2 weeks of 100mg AZD0530 daily will receive 125mg daily of AZD0530.'}, {'id': 'BG001', 'title': 'AZD0530 Placebo', 'description': '50% of patients will receive placebo treatment for the duration of the study,\n\nPlacebo: 50% of patients will receive placebo treatment for the duration of the study.'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White (not Hispanic)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-31', 'size': 729058, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-19T13:51', 'hasProtocol': True}]}}, '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': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2014-06-12', 'resultsFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-25', 'studyFirstPostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging', 'timeFrame': '12 months', 'description': 'Composite measure of brain glucose uptake using F18-FDG PET in a pre-defined set of brain regions, between baseline and 12 months.'}, {'measure': 'Number of Participants With One or More Serious/Other Adverse Events Subjects With Mild AD as Assessed by Analysis of Adverse Events, Including Symptoms, and Abnormal Findings on Physical and Neurological Examinations, and Standard Labs.', 'timeFrame': '12 months', 'description': 'Assessment of any adverse effects between drug and placebo-treated subjects'}], 'secondaryOutcomes': [{'measure': 'The Effect of Treatment With AZD0530 on Cognitive and Behavioral Function', 'timeFrame': '12 months', 'description': 'The change in cognitive function between baseline and 12 months will be measured by the following tests:\n\n1. Alzheimer Disease Assessment Scale - Cognitive 11 (ADAS-cog11). Measures: Cognitive function Maximum score: 70; Minimum score: 0. Higher score equals worse cognitive function\n2. Mini-Mental State Examination (MMSE) Measures: Cognitive Function Maximum score: 30; Minimum score: 0. Higher score equal better cognitive function\n3. Alzheimer Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Measures: Ability to perform routine daily activities Maximum score: 78; Minimum score: 0. Higher score equals better ability to perform activities of daily living\n4. Clinical Dementia Rating Sum of Boxes (CDR-SO) Measures: Dementia severity Maximum score: 18; Minimum score: 0. Higher score equals more severe dementia.'}, {'measure': 'Percent Change in Brain Volume Before and After Treatment', 'timeFrame': '12 months', 'description': 'Change in volume of pre-defined brain regions between baseline and 12 months of treatment.'}, {'measure': 'Cerebrospinal Fluid Levels of Total Tau, Phospho-tau (p-Tau), and Amyloid-beta 1-42 (Abeta 1-42)', 'timeFrame': '12 months', 'description': 'Measure concentration of Tau and Amyloid-beta 1-42 biomarkers in the cerebrospinal fluid between baseline and 12 months of treatment'}, {'measure': 'Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging', 'timeFrame': '12 months', 'description': 'The results from the primary outcome with brain FDG-PET imaging was analyzed by ApoE genotype. Composite measure of brain glucose uptake using F18-FDG PET in a pre-defined set of brain regions, between baseline and 12 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '36627206', 'type': 'DERIVED', 'citation': "Donohue MC, Langford O, Insel PS, van Dyck CH, Petersen RC, Craft S, Sethuraman G, Raman R, Aisen PS; Alzheimer's Disease Neuroimaging Initiative. Natural cubic splines for the analysis of Alzheimer's clinical trials. Pharm Stat. 2023 May-Jun;22(3):508-519. doi: 10.1002/pst.2285. Epub 2023 Jan 10."}, {'pmid': '31329216', 'type': 'DERIVED', 'citation': 'van Dyck CH, Nygaard HB, Chen K, Donohue MC, Raman R, Rissman RA, Brewer JB, Koeppe RA, Chow TW, Rafii MS, Gessert D, Choi J, Turner RS, Kaye JA, Gale SA, Reiman EM, Aisen PS, Strittmatter SM. Effect of AZD0530 on Cerebral Metabolic Decline in Alzheimer Disease: A Randomized Clinical Trial. JAMA Neurol. 2019 Oct 1;76(10):1219-1229. doi: 10.1001/jamaneurol.2019.2050.'}]}, 'descriptionModule': {'briefSummary': "AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment for malignancies because these kinases play a role in tumor invasion and proliferation. However, the Src family kinases (SFKs) are highly expressed in brain and have major effects on synaptic plasticity2. Moreover, the investigators have recently shown that a specific SFK, namely Fyn, is aberrantly activated by specific conformations of the Amyloid Beta (Aß) peptide from Alzheimer's disease (AD). Genetic deletion of Fyn rescues AD deficits in preclinical models. This clinical trial will test the potential benefit of AZD0530 for Alzheimer's disease modification."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. NIA-Alzheimer's Association core clinical criteria for probable AD\n2. 18F-Florbetapir scan with evidence of elevated Aβ (based on central review)\n3. Age between 55-85 (inclusive)\n4. MMSE score between 18 and 26 (inclusive)\n5. Stability of permitted medications for 4 weeks. In particular:\n\n * Stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 year)\n * Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screen\n6. Geriatric Depression Scale less than 6 \\[Note: a score ≥6 on this screening scale may be permissible, if the subject is examined by a site clinician and judged not to be depressed.\\]\n7. Study partner is available who has frequent contact with the subject (e.g., average of 10 hours per week or more), and can accompany the subject to most visits to answer questions about the subject\n8. Visual and auditory acuity adequate for neuropsychological testing\n9. Good general health with no disease expected to interfere with the study\n10. Subject is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)\n11. Modified Hachinski less than or equal to 4\n12. Completed six grades of education or has a good work history\n13. Must speak English or Spanish fluently\n\nExclusion Criteria\n\n1. Any significant neurologic disease other than AD, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities\n2. Screening/baseline MRI scan with evidence of infection, infarction, or other focal lesions or multiple lacunes or lacunes in a critical memory structure\n3. Subjects that have any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker\n4. Major depression, bipolar disorder as described in DSM-IV within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol\n5. History of schizophrenia (DSM V criteria)\n6. History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria)\n7. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.\n8. Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment\n9. Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.\n10. Residence in skilled nursing facility.\n11. Use of any excluded medication as described in study protocol\n12. Current or recent participation in any procedures involving radioactive agents, including current, past, or anticipated exposure to radiation in the workplace, such that the total radiation dose exposure to the subject in a given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1. This guideline is an effective dose of 5 rem received per year.\n13. Neutropenia defined as absolute neutrophils count of \\<1,800/microliter\n14. Thrombocytopenia defined as platelet count \\<120x103/microliter\n15. For CSF sub-study participants, a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening\n16. Clinically significant abnormalities in screening laboratories, including:\n\n * Aspartate aminotransferase (AST) \\>1.5 times ULN\n * Alanine aminotransferase (ALT) \\> 1.5 times ULN\n * Total bilirubin \\>1.5 times ULN\n * Serum creatinine \\>2.0 times ULN\n17. History of interstitial lung disease\n18. Patients whom the PI deems to be otherwise ineligible"}, 'identificationModule': {'nctId': 'NCT02167256', 'briefTitle': "A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': "A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease", 'orgStudyIdInfo': {'id': '1404013830'}, 'secondaryIdInfos': [{'id': '4UH3TR000967-02', 'link': 'https://reporter.nih.gov/quickSearch/4UH3TR000967-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD0530 100mg daily', 'description': 'Patients in the experimental group (50%) will be started on this dose. After 2 weeks, patients with a plasma drug level of \\<100ng/ml will receive 125mg AZD0530 daily and remain in the same experimental group as patient receiving 100mg daily.', 'interventionNames': ['Drug: AZD0530 100mg daily', 'Drug: AZD0530 125mg daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'AZD0530 Placebo', 'description': '50% of patients will receive placebo treatment for the duration of the study,', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD0530 100mg daily', 'type': 'DRUG', 'otherNames': ['saracatinib'], 'description': 'All patients in experimental group (50%) will be started on 100mg AZD0530 daily', 'armGroupLabels': ['AZD0530 100mg daily']}, {'name': 'AZD0530 125mg daily', 'type': 'DRUG', 'otherNames': ['saracatinib'], 'description': 'Patients with plasma drug level \\<100ng/ml after 2 weeks of 100mg AZD0530 daily will receive 125mg daily of AZD0530.', 'armGroupLabels': ['AZD0530 100mg daily']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['saracatinib'], 'description': '50% of patients will receive placebo treatment for the duration of the study.', 'armGroupLabels': ['AZD0530 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Sun Health Research Institute', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': "Yale Alzheimer's Disease Research Unit", 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Wien Center for Clinical Research/Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida - Health Byrd Alzheimer Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48105-2945', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan, Ann Arbor', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "University of Pittsburgh, Alzheimer's Disease Research Center", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Roper St. Francis Hospital', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'V6T 1Z3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia, Clinic for AD & Related Disorders', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Christopher H van Dyck, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yale University'}, {'name': 'Paul Aisen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "USC Alzheimer's Therapeutic Research Institute (ATRI)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': "Alzheimer's Therapeutic Research Institute", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology and Neurobiology', 'investigatorFullName': 'Stephen M. Strittmatter', 'investigatorAffiliation': 'Yale University'}}}}