Health Evaluation in African Americans Using RAS Therapy

NCT ID: NCT02471833

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2022-04-15

Brief 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.

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Telmisartan 20mg

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.

Group Type: EXPERIMENTAL

Telmisartan 20mg

Intervention Type: DRUG

Participants will be given 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.

Telmisartan 40mg

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.

Group Type: EXPERIMENTAL

Telmisartan 40mg

Intervention Type: DRUG

Participants will be given 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will be given placebo to be taken orally once a day before bedtime, for a duration of 8 months.

Interventions

Telmisartan 20mg

Participants will be given 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.

Intervention Type: DRUG

Telmisartan 40mg

Participants will be given 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.

Intervention Type: DRUG

Placebo

Participants will be given placebo to be taken orally once a day before bedtime, for a duration of 8 months.

Intervention Type: DRUG

Other Intervention Names

Micardis; Micardis

Eligibility Criteria

Inclusion Criteria

• Mean resting systolic blood pressure ≥ 110 mmHg and ≤ 170 mmHg
• Family history of Alzheimer's disease
• African American

Exclusion Criteria

• Currently in another investigational drug study
• Potassium >5.0 meq/dL at baseline
• Creatinine >1.99 mg/dL at baseline
• History of stroke or transient ischemic attack (TIA)
• Dementia
• Current use of a RAS acting medication
• Contraindication for lumbar puncture or magnetic resonance imaging
• Heart failure
• Diabetes Types I and II
• Pregnant or nursing women

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Whitney Wharton

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Whitney Whitney, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29254080 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1RF1AG051514

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00080192

Identifier Type: -

Identifier Source: org_study_id