Repurposing a Combination Antiretroviral Drug Therapy to Target Retrotransposons and Treat Early Alzheimer's Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor: Brigham and Women's Hospital
Study ID: NCT07795307
Phase: PHASE1
Status: Not Yet Recruiting

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Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: ALL
Age: 55 Years - 85 Years
Healthy Volunteers: Not accepted

Interventions

Emtricitabine and tenofovir disoproxil fumarate combination — DRUG
FTC and TDF combination tablets at two dose strengths that are in clinical use: 133 mg FTC plus 200 mg TDF, and 200 mg FTC plus 300 mg TDF.
Placebo — DRUG
Placebo tablets.

Study Details

The goal of this clinical trial is to determine the safety, tolerability, drug levels and biological effects of two doses of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) combination administered daily for 4 weeks in older adults with early Alzheimer's disease. The main questions it aims to answer are: * Is FTC-TDF combination safe in older adults who have early Alzheimer's disease. * To measure the FTC-TDF levels at different times. * To measure the biological effects of FTC-TDF combination. * To measure the effects of FTC-TDF combination on inflammation. Researchers will compare two doses of FTC-TDF combination to a placebo (a look-alike substance that contains no drug) to see if FTC-TDF combination is safe in older adults who have early Alzheimer's disease. Participants will: * Take FTC-TDF combination or a placebo every day for 28 days. * Have 10 clinic visits over approximately 3 months. * Undergo blood tests, physical exams, cognitive testing, and scans of their brain.

Key Dates

First listed: Aug 31, 2026
Start date: Dec 31, 2026
Status verified: Aug 2026
Primary completion: Jul 31, 2028
Completion: Sep 30, 2028

Study Design

Enrollment: 20 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: FTC and TDF combination tablet
FTC and TDF combination tablets at two dose strengths that are in clinical use: 133 mg FTC plus 200 mg TDF, and 200 mg FTC plus 300 mg TDF. There is a 70% chance participants will receive the FTC-TDF combination.
Placebo Comparator: Placebo
Placebo tablets. There is a 30% chance participants will receive placebo.