Viewing Study NCT02471833


Ignite Creation Date: 2025-12-25 @ 2:46 AM
Ignite Modification Date: 2026-03-02 @ 3:43 PM
Study NCT ID: NCT02471833
Status: COMPLETED
Last Update Posted: 2024-05-23
First Post: 2015-06-10
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Health Evaluation in African Americans Using RAS Therapy
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'w.wharton@emory.edu', 'phone': '404-712-7359', 'title': 'Whitney Wharton, PhD', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Unanticipated expenses related to the Coronavirus Disease 2019 (COVID-19) pandemic resulted in less funds toward the end of this study impacting the post processing of neuroimaging scans.The researchers are submitting for additional funding for imaging processing and analyses, as well as searching for an expert who is available to perform imaging processing. Results for the magnetic resonance imaging outcomes will be reported as soon as possible.'}}, 'adverseEventsModule': {'timeFrame': 'Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.', 'description': 'Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.', 'eventGroups': [{'id': 'EG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.", 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 13, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.", 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 13, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.", 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 15, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Excessive swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal kidney function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unusual muscle aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Out of range labs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased body temperature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acid reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Trouble falling asleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty swallowing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low energy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concentration of Angiotensin Converting Enzyme (ACE 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4043.15', 'spread': '1425.34', 'groupId': 'OG000'}, {'value': '4028.17', 'spread': '1509.02', 'groupId': 'OG001'}, {'value': '3836.31', 'spread': '1627.50', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3305.21', 'spread': '764.54', 'groupId': 'OG000'}, {'value': '4102.96', 'spread': '1498.07', 'groupId': 'OG001'}, {'value': '3696.71', 'spread': '1309.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'The cerebrospinal fluid renin-angiotensin system (RAS) was assessed by measuring levels of angiotensin metabolites in a 1 milliliter (mL) sample of cerebrospinal fluid (CSF). ACE 1 helps to regulate blood pressure by converting angiotensin I to angiotensin II.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'PRIMARY', 'title': 'Concentration of Angiotensin Converting Enzyme 2 (ACE 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '889.06', 'spread': '870.83', 'groupId': 'OG000'}, {'value': '566.43', 'spread': '700.13', 'groupId': 'OG001'}, {'value': '783.72', 'spread': '998.95', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '231.86', 'spread': '47.66', 'groupId': 'OG000'}, {'value': '274.17', 'spread': '84.74', 'groupId': 'OG001'}, {'value': '264.83', 'spread': '109.40', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': "The cerebrospinal fluid renin-angiotensin system (RAS) was assessed by measuring levels of angiotensin metabolites in a 1 milliliter (mL) sample of cerebrospinal fluid (CSF). ACE 2 regulates levels of circulating angiotensin II. ACE 2 increases during illness and with Alzheimer's disease.", 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'PRIMARY', 'title': 'Cerebrospinal Fluid Amyloid β40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7704.82', 'spread': '2237.94', 'groupId': 'OG000'}, {'value': '9121.62', 'spread': '3174.21', 'groupId': 'OG001'}, {'value': '8259.13', 'spread': '2176.62', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8011.44', 'spread': '2688.34', 'groupId': 'OG000'}, {'value': '8820.08', 'spread': '2514.47', 'groupId': 'OG001'}, {'value': '8300.67', 'spread': '2623.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'Levels of amyloid β40 (Aβ40) in the cerebrospinal fluid were measured using LUMIPULSE® technology. The relationship between Aβ40 is non-linear with moderate levels showing the highest risk of future cognitive decline in some studies.', 'unitOfMeasure': 'picograms per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'PRIMARY', 'title': 'Levels of Cerebrospinal Fluid Amyloid β42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '611.91', 'spread': '138.51', 'groupId': 'OG000'}, {'value': '614.54', 'spread': '193.54', 'groupId': 'OG001'}, {'value': '578.31', 'spread': '190.75', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '620.89', 'spread': '256.43', 'groupId': 'OG000'}, {'value': '665.42', 'spread': '278.00', 'groupId': 'OG001'}, {'value': '599.25', 'spread': '204.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'Levels of amyloid β42 (Aβ42) in the cerebrospinal fluid were measured using LUMIPULSE® technology. Decreases in concentrations of amyloid β42 are indicative of a decrease in cognitive function.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'PRIMARY', 'title': 'Levels of Cerebrospinal Fluid T-tau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '347.73', 'spread': '371.85', 'groupId': 'OG000'}, {'value': '281.23', 'spread': '89.72', 'groupId': 'OG001'}, {'value': '248.94', 'spread': '107.67', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '393.11', 'spread': '404.35', 'groupId': 'OG000'}, {'value': '266.58', 'spread': '83.23', 'groupId': 'OG001'}, {'value': '244.58', 'spread': '67.04', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'Levels of T-tau in the cerebrospinal fluid were measured using LUMIPULSE® technology. Increases in concentrations of T-tau are indicative of a decrease in cognitive function.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'PRIMARY', 'title': 'Levels of Cerebrospinal Fluid P-tau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.75', 'spread': '12.88', 'groupId': 'OG000'}, {'value': '36.55', 'spread': '11.24', 'groupId': 'OG001'}, {'value': '31.58', 'spread': '13.24', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.48', 'spread': '10.16', 'groupId': 'OG000'}, {'value': '35.68', 'spread': '13.67', 'groupId': 'OG001'}, {'value': '30.48', 'spread': '10.30', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'Levels of P-tau in the cerebrospinal fluid were measured using LUMIPULSE® technology. Increases in concentrations of P-tau are indicative of a decrease in cognitive function.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Interleukin-6 (IL-6) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.41', 'spread': '3.25', 'groupId': 'OG000'}, {'value': '10.65', 'spread': '6.77', 'groupId': 'OG001'}, {'value': '8.62', 'spread': '3.08', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.51', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '8.69', 'spread': '4.14', 'groupId': 'OG001'}, {'value': '8.19', 'spread': '3.23', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'The inflammatory marker IL-6 in CSF was examined.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Interleukin-7 (IL-7) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.88', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '1.77', 'spread': '1.17', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.06', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '1.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'The inflammatory marker IL-7 in CSF was examined.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Interleukin-8 (IL-8) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '123.77', 'spread': '64.31', 'groupId': 'OG000'}, {'value': '156.99', 'spread': '49.10', 'groupId': 'OG001'}, {'value': '165.40', 'spread': '100.25', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '103.31', 'spread': '42.88', 'groupId': 'OG000'}, {'value': '102.11', 'spread': '25.84', 'groupId': 'OG001'}, {'value': '122.99', 'spread': '51.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'The inflammatory marker IL-8 in CSF was examined.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Interleukin-9 (IL-9) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.55', 'spread': '64.31', 'groupId': 'OG000'}, {'value': '153.65', 'spread': '71.26', 'groupId': 'OG001'}, {'value': '119.18', 'spread': '79.53', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '81.24', 'spread': '34.06', 'groupId': 'OG000'}, {'value': '98.32', 'spread': '28.48', 'groupId': 'OG001'}, {'value': '88.22', 'spread': '39.96', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'The inflammatory marker IL-9 in CSF was examined.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Interleukin-10 (IL-10) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.70', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '11.93', 'spread': '3.32', 'groupId': 'OG001'}, {'value': '10.92', 'spread': '3.09', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.83', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '10.15', 'spread': '2.85', 'groupId': 'OG001'}, {'value': '10.60', 'spread': '2.26', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'The inflammatory marker IL-10 in CSF was examined.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Monocyte Chemoattractant Protein 1 (MCP-1) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3369.30', 'spread': '1180.22', 'groupId': 'OG000'}, {'value': '3347.26', 'spread': '786.79', 'groupId': 'OG001'}, {'value': '3606.96', 'spread': '1077.71', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2069.32', 'spread': '735.75', 'groupId': 'OG000'}, {'value': '2343.98', 'spread': '487.36', 'groupId': 'OG001'}, {'value': '2548.37', 'spread': '872.88', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'Monocyte chemoattractant protein 1 inflammatory markers in CSF were examined.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Macrophage Derived Protein 1 (MDC-1) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.68', 'spread': '30.61', 'groupId': 'OG000'}, {'value': '13.12', 'spread': '22.27', 'groupId': 'OG001'}, {'value': '30.88', 'spread': '67.71', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.70', 'spread': '4.84', 'groupId': 'OG000'}, {'value': '9.47', 'spread': '5.46', 'groupId': 'OG001'}, {'value': '10.40', 'spread': '4.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'Macrophage derived protein 1 inflammatory markers in CSF were examined.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Transforming Growth Factor Alpha (TGF-α) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.42', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '9.58', 'spread': '1.65', 'groupId': 'OG001'}, {'value': '9.05', 'spread': '1.71', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.56', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '7.07', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '7.25', 'spread': '1.25', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'Transforming growth factor alpha inflammatory markers in CSF were examined.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Tumor Necrosis Factor Alpha (TNF-α) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.54', 'spread': '4.12', 'groupId': 'OG000'}, {'value': '6.72', 'spread': '4.68', 'groupId': 'OG001'}, {'value': '5.17', 'spread': '3.28', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.96', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '3.12', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '4.71', 'spread': '8.63', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'Tumor necrosis factor alpha inflammatory markers in CSF were examined.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Intercellular Adhesion Molecule 1 (ICAM-1) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '207.81', 'spread': '107.74', 'groupId': 'OG000'}, {'value': '310.55', 'spread': '258.73', 'groupId': 'OG001'}, {'value': '205.18', 'spread': '179.56', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '472.01', 'spread': '385.47', 'groupId': 'OG000'}, {'value': '461.41', 'spread': '290.66', 'groupId': 'OG001'}, {'value': '591.69', 'spread': '494.44', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'Intercellular adhesion molecule 1 inflammatory markers in CSF were examined.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Vascular Cell Adhesion Molecule 1 (VCAM-1) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12585.04', 'spread': '10891.20', 'groupId': 'OG000'}, {'value': '16838.79', 'spread': '9151.95', 'groupId': 'OG001'}, {'value': '13807.56', 'spread': '8991.60', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12964.43', 'spread': '2893.44', 'groupId': 'OG000'}, {'value': '172781.50', 'spread': '4513.46', 'groupId': 'OG001'}, {'value': '19212.32', 'spread': '8557.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'Vascular cell adhesion molecule 1 inflammatory markers in CSF were examined.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'SECONDARY', 'title': 'Matrix Metalloproteinase (MMP) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'timeFrame': 'Baseline, Month 8', 'description': 'Matrix metalloproteinase inflammatory markers will be examined in CSF.', 'reportingStatus': 'POSTED', 'populationDescription': 'MMP was not analyzed because since developing the protocol for this study much has been learned about inflammatory cytokines and chemokines as AD preclinical biomarkers. The biological assay menu options for group analyses changed to include only those that have been shown to be related to disease state and likelihood of progression. The marker MMP was removed from the preplanned menu of inflammatory markers by the manufacturer and having MMP analyzed independently was cost prohibitive.'}, {'type': 'SECONDARY', 'title': 'Tissue Inhibitor of Metalloproteinase (TIMP) Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'timeFrame': 'Baseline, Month 8', 'description': 'Tissue inhibitor of metalloproteinase inflammatory markers will be examined in CSF.', 'reportingStatus': 'POSTED', 'populationDescription': 'TIMP was not analyzed because since developing the protocol for this study much has been learned about inflammatory cytokines and chemokines as AD preclinical biomarkers. The biological assay menu options for group analyses changed to include only those that have been shown to be related to disease state and likelihood of progression. The marker TIMP was removed from the preplanned menu of inflammatory markers by the manufacturer and having TIMP analyzed independently was cost prohibitive.'}, {'type': 'SECONDARY', 'title': 'CSF-Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'OG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '600.30', 'spread': '299.60', 'groupId': 'OG000'}, {'value': '432.02', 'spread': '210.85', 'groupId': 'OG001'}, {'value': '403.74', 'spread': '156.44', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '470.93', 'spread': '104.50', 'groupId': 'OG000'}, {'value': '391.10', 'spread': '151.23', 'groupId': 'OG001'}, {'value': '471.60', 'spread': '190.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 8', 'description': 'Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ) is a marker of breakdown in the blood brain barrier. Increased levels of sPDGFRβ indicate cognitive dysfunction.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Structural Magnetic Resonance Imaging and White Matter Hyperintensities', 'timeFrame': 'Baseline, Month 8', 'description': 'High-resolution anatomical images will be acquired using a 3D-Fast Spoiled Gradient Recalled Echo (FSPGR) Sequence. White Matter Hyperintensities (WMH) will be identified by a 3D T2 Fluid Attenuated Inversion Recovery (FLAIR) Fast Spin Echo sequence. The images will be co-registered using a within-subject inter-modal alignment between structural and perfusion images. T1-weighted Spoiled Gradient Recalled (SPGR) images will be used to identify cerebrospinal fluid and white and gray matter. Increased volumes of white matter hyperintensities indicate impaired cognitive function.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Arterial Spin Labeling-Magnetic Resonance Imaging', 'timeFrame': 'Baseline, Month 8', 'description': 'Echoplanar T1 mapping scans will be used for image registration and a scout image of the head will be obtained in order to choose the appropriate location for spin labeling and flow imaging. Arterial Spin Labeling images will be acquired using a custom 3D stack of interleaved spirals fast spin echo sequences and will be averaged in order to improve the signal-to-noise ratio. Images will be interpolated and smoothed in a panel by using a 0.5-pixel, full-width, half-maximum Gaussian kernel. Regional perfusion will be quantified in each hemisphere and maps of cerebral vasoreactivity will be obtained by co-registration of perfusion and anatomical images.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease (AD) who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'FG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'FG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'Completed 8 Months of Study Treatment', 'comment': 'Four participants in the Telmisartan 20mg group, 1 participant in the Telmisartan 40mg group, and 2 participants in the Placebo group were withdrawn from study medication prior to completing 8 months of treatment. These participants attended the Month 8 study visit and are considered as completing the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'recruitmentDetails': "Participants were recruited from the Wesley Woods Health Center, Emory Alzheimer's Clinical Research Unit (ACRU), and the Emory Brain Health Center in Atlanta, Georgia, USA. Participant enrollment began April 2015 and all follow-up assessments were completed by April 15, 2022."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'BG001', 'title': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'BG002', 'title': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.79', 'spread': '8.85', 'groupId': 'BG000'}, {'value': '60.44', 'spread': '7.48', 'groupId': 'BG001'}, {'value': '60.54', 'spread': '8.65', 'groupId': 'BG002'}, {'value': '59.66', 'spread': '8.48', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '19.', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-10', 'size': 585203, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-08T16:33', 'hasProtocol': True}, {'date': '2021-01-13', 'size': 390770, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-06T13:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'dispFirstSubmitDate': '2023-04-11', 'completionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2015-06-10', 'resultsFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2015-06-11', 'dispFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-30', 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Structural Magnetic Resonance Imaging and White Matter Hyperintensities', 'timeFrame': 'Baseline, Month 8', 'description': 'High-resolution anatomical images will be acquired using a 3D-Fast Spoiled Gradient Recalled Echo (FSPGR) Sequence. White Matter Hyperintensities (WMH) will be identified by a 3D T2 Fluid Attenuated Inversion Recovery (FLAIR) Fast Spin Echo sequence. The images will be co-registered using a within-subject inter-modal alignment between structural and perfusion images. T1-weighted Spoiled Gradient Recalled (SPGR) images will be used to identify cerebrospinal fluid and white and gray matter. Increased volumes of white matter hyperintensities indicate impaired cognitive function.'}, {'measure': 'Change in Arterial Spin Labeling-Magnetic Resonance Imaging', 'timeFrame': 'Baseline, Month 8', 'description': 'Echoplanar T1 mapping scans will be used for image registration and a scout image of the head will be obtained in order to choose the appropriate location for spin labeling and flow imaging. Arterial Spin Labeling images will be acquired using a custom 3D stack of interleaved spirals fast spin echo sequences and will be averaged in order to improve the signal-to-noise ratio. Images will be interpolated and smoothed in a panel by using a 0.5-pixel, full-width, half-maximum Gaussian kernel. Regional perfusion will be quantified in each hemisphere and maps of cerebral vasoreactivity will be obtained by co-registration of perfusion and anatomical images.'}], 'primaryOutcomes': [{'measure': 'Concentration of Angiotensin Converting Enzyme (ACE 1)', 'timeFrame': 'Baseline, Month 8', 'description': 'The cerebrospinal fluid renin-angiotensin system (RAS) was assessed by measuring levels of angiotensin metabolites in a 1 milliliter (mL) sample of cerebrospinal fluid (CSF). ACE 1 helps to regulate blood pressure by converting angiotensin I to angiotensin II.'}, {'measure': 'Concentration of Angiotensin Converting Enzyme 2 (ACE 2)', 'timeFrame': 'Baseline, Month 8', 'description': "The cerebrospinal fluid renin-angiotensin system (RAS) was assessed by measuring levels of angiotensin metabolites in a 1 milliliter (mL) sample of cerebrospinal fluid (CSF). ACE 2 regulates levels of circulating angiotensin II. ACE 2 increases during illness and with Alzheimer's disease."}, {'measure': 'Cerebrospinal Fluid Amyloid β40', 'timeFrame': 'Baseline, Month 8', 'description': 'Levels of amyloid β40 (Aβ40) in the cerebrospinal fluid were measured using LUMIPULSE® technology. The relationship between Aβ40 is non-linear with moderate levels showing the highest risk of future cognitive decline in some studies.'}, {'measure': 'Levels of Cerebrospinal Fluid Amyloid β42', 'timeFrame': 'Baseline, Month 8', 'description': 'Levels of amyloid β42 (Aβ42) in the cerebrospinal fluid were measured using LUMIPULSE® technology. Decreases in concentrations of amyloid β42 are indicative of a decrease in cognitive function.'}, {'measure': 'Levels of Cerebrospinal Fluid T-tau', 'timeFrame': 'Baseline, Month 8', 'description': 'Levels of T-tau in the cerebrospinal fluid were measured using LUMIPULSE® technology. Increases in concentrations of T-tau are indicative of a decrease in cognitive function.'}, {'measure': 'Levels of Cerebrospinal Fluid P-tau', 'timeFrame': 'Baseline, Month 8', 'description': 'Levels of P-tau in the cerebrospinal fluid were measured using LUMIPULSE® technology. Increases in concentrations of P-tau are indicative of a decrease in cognitive function.'}], 'secondaryOutcomes': [{'measure': 'Interleukin-6 (IL-6) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'The inflammatory marker IL-6 in CSF was examined.'}, {'measure': 'Interleukin-7 (IL-7) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'The inflammatory marker IL-7 in CSF was examined.'}, {'measure': 'Interleukin-8 (IL-8) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'The inflammatory marker IL-8 in CSF was examined.'}, {'measure': 'Interleukin-9 (IL-9) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'The inflammatory marker IL-9 in CSF was examined.'}, {'measure': 'Interleukin-10 (IL-10) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'The inflammatory marker IL-10 in CSF was examined.'}, {'measure': 'Monocyte Chemoattractant Protein 1 (MCP-1) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'Monocyte chemoattractant protein 1 inflammatory markers in CSF were examined.'}, {'measure': 'Macrophage Derived Protein 1 (MDC-1) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'Macrophage derived protein 1 inflammatory markers in CSF were examined.'}, {'measure': 'Transforming Growth Factor Alpha (TGF-α) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'Transforming growth factor alpha inflammatory markers in CSF were examined.'}, {'measure': 'Tumor Necrosis Factor Alpha (TNF-α) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'Tumor necrosis factor alpha inflammatory markers in CSF were examined.'}, {'measure': 'Intercellular Adhesion Molecule 1 (ICAM-1) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'Intercellular adhesion molecule 1 inflammatory markers in CSF were examined.'}, {'measure': 'Vascular Cell Adhesion Molecule 1 (VCAM-1) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'Vascular cell adhesion molecule 1 inflammatory markers in CSF were examined.'}, {'measure': 'Matrix Metalloproteinase (MMP) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'Matrix metalloproteinase inflammatory markers will be examined in CSF.'}, {'measure': 'Tissue Inhibitor of Metalloproteinase (TIMP) Frequency', 'timeFrame': 'Baseline, Month 8', 'description': 'Tissue inhibitor of metalloproteinase inflammatory markers will be examined in CSF.'}, {'measure': 'CSF-Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ)', 'timeFrame': 'Baseline, Month 8', 'description': 'Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ) is a marker of breakdown in the blood brain barrier. Increased levels of sPDGFRβ indicate cognitive dysfunction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'prevention', 'family history', 'inflammation', 'blood brain barrier', 'amyloid'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '29254080', 'type': 'BACKGROUND', 'citation': "Wharton W, Goldstein FC, Tansey MG, Brown AL, Tharwani SD, Verble DD, Cintron A, Kehoe PG. Rationale and Design of the Mechanistic Potential of Antihypertensives in Preclinical Alzheimer's (HEART) Trial. J Alzheimers Dis. 2018;61(2):815-824. doi: 10.3233/JAD-161198."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if telmisartan, an FDA approved blood pressure medication, may also have beneficial effects on Alzheimer's disease prevention in African Americans, who are at high risk for Alzheimer's disease.", 'detailedDescription': "This study will assess if telmisartan, an FDA approved blood pressure medication, may also have beneficial effects on Alzheimer's disease (AD) prevention in African Americans, who are at high risk for Alzheimer's disease. Blood pressure medications known as angiotensin-receptor blockers have been associated with reduced risk of Alzheimer's in Caucasians because they act on the renin-angiotensin system (RAS), a key regulator of blood pressure in the body and the brain. The drugs appear to slow the progression of the disease by affecting flow of blood and the amount of plaque in the brain, but these benefits have not been tested in African Americans. The investigator will evaluate if telmisartan is able to influence the renin-angiotensin system in the brain and produce favorable effects on brain blood flow and enzymes that cause the brain plaques in Alzheimer's disease.The investigator will assess the mechanism by which telmisartan modifies the brain renin angiotensin system, cerebrospinal fluid amyloid-β, cerebral blood flow (CBF) and inflammatory markers in hypertensive African Americans."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Mean resting systolic blood pressure ≥ 110 mmHg and ≤ 170 mmHg\n* Family history of Alzheimer's disease\n* African American\n\nExclusion Criteria:\n\n* Currently in another investigational drug study\n* Potassium \\>5.0 meq/dL at baseline\n* Creatinine \\>1.99 mg/dL at baseline\n* History of stroke or transient ischemic attack (TIA)\n* Dementia\n* Current use of a RAS acting medication\n* Contraindication for lumbar puncture or magnetic resonance imaging\n* Heart failure\n* Diabetes Types I and II\n* Pregnant or nursing women"}, 'identificationModule': {'nctId': 'NCT02471833', 'acronym': 'HEART', 'briefTitle': 'Health Evaluation in African Americans Using RAS Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Health Evaluation in African Americans Using RAS Therapy', 'orgStudyIdInfo': {'id': 'IRB00080192'}, 'secondaryIdInfos': [{'id': '1RF1AG051514', 'link': 'https://reporter.nih.gov/quickSearch/1RF1AG051514', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telmisartan 20mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who are randomly assigned to receive telmisartan 20mg once a day orally.", 'interventionNames': ['Drug: Telmisartan 20mg']}, {'type': 'EXPERIMENTAL', 'label': 'Telmisartan 40mg', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who are randomly assigned to receive telmisartan 40mg once a day orally.", 'interventionNames': ['Drug: Telmisartan 40mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who are randomly assigned to receive a placebo to match telmisartan once a day orally.", 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Telmisartan 20mg', 'type': 'DRUG', 'otherNames': ['Micardis'], 'description': 'Participants will be given 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.', 'armGroupLabels': ['Telmisartan 20mg']}, {'name': 'Telmisartan 40mg', 'type': 'DRUG', 'otherNames': ['Micardis'], 'description': 'Participants will be given 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.', 'armGroupLabels': ['Telmisartan 40mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will be given placebo to be taken orally once a day before bedtime, for a duration of 8 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Whitney Whitney, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Whitney Wharton', 'investigatorAffiliation': 'Emory University'}}}}