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 angiotensinogenChange 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
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