FTC-TDF for Early Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Gad A Marshall, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for older adults diagnosed with early Alzheimer's disease. Participants should be generally healthy aside from their Alzheimer's and able to attend multiple clinic visits over about three months.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Emtricitabine and tenofovir disoproxil fumarate combination
Trial Overview
The study tests two different doses of a combination HIV drug (emtricitabine and tenofovir disoproxil fumarate) taken daily for four weeks, compared to a placebo, to see if the drugs are safe and what effects they have in people with early Alzheimer's.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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 tablets. There is a 30% chance participants will receive placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.