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

NCT07795307 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Emtricitabine and tenofovir disoproxil fumarate combination

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.

DRUG

Placebo

Placebo tablets.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Gad A Marshall, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-07-31
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07795307 on ClinicalTrials.gov