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Health Evaluation in African Americans Using RAS Therapy

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease

Intervention: Telmisartan 20mg (Drug); Telmisartan 40mg (Drug); Placebo (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Whitney Whitney, PhD, Principal Investigator, Affiliation: Emory University

Overall contact:
Whitney Wharton, PhD, Phone: 404-712-7359, Email: w.wharton@emory.edu

Summary

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.

Clinical Details

Official title: Health Evaluation in African Americans Using RAS Therapy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Change in concentration of cerebrospinal fluid angiotensin metabolites

Secondary outcome:

Change in levels of plasma angiotensinogen

Change in levels of plasma angiotensinogen

Change in levels of plasma renin

Change in levels of plasma renin

Change in levels of plasma angiotensin converting enzyme

Change in levels of plasma angiotensin converting enzyme

Change in levels of plasma aldosterone

Change in levels of plasma aldosterone

Change in levels of cerebrospinal fluid amyloid β42

Change in levels of cerebrospinal fluid T-tau

Change in levels of cerebrospinal fluid P-tau

Change in arterial function

Flanker Inhibitory Control and Attention Test

Set-shifting Test

Spatial 1-Back Test

Montreal Cognitive Assessment

Mini Mental State Examination (MMSE)

Wechsler Adult Intelligence Scale (WAIS)-Working Memory subtests

Wechsler Memory Scale-III Faces Test

Wechsler Memory Scale-Revised Logical Memory Test

Rey Auditory Verbal Learning Test

Arterial Spin Labeling-Magnetic Resonance Imaging

Structural Magnetic Resonance Imaging and White Matter Hyperintensities

Detailed description: 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.

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Treated hypertension (systolic blood pressure >100 mmHg systolic and < 200 mmHg 2. Parent with Alzheimer's disease 3. African American Exclusion Criteria: 1. Mean resting blood pressure >200 systolic or diastolic >110 mmHg 2. Currently in another investigational drug study 3. Past or current use of renin-angiotensin acting medication 4. Potassium >5. 5 meq/dl at baseline 5. Creatinine >1. 99 mg/dl at baseline 6. History of stroke 7. Dementia 8. Baseline Montreal Cognitive Assessment score <27 9. Contraindication for lumbar puncture or magnetic resonance imaging 10. Heart failure 11. Diabetes Types I and II 12. Pregnant or nursing women

Locations and Contacts

Whitney Wharton, PhD, Phone: 404-712-7359, Email: w.wharton@emory.edu

Emory University, Atlanta, Georgia 30322, United States; Recruiting
Whitney Wharton, PhD, Phone: 404-712-7359, Email: w.wharton@emory.edu
Additional Information

Starting date: April 2015
Last updated: June 11, 2015

Page last updated: August 23, 2015

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