Brigham and Women's Hospital
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.
Objectives: To conduct a phase 1b trial to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple ascending doses of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) combination administered daily for 4 weeks in older adults with early Alzheimer's disease (AD). Primary: 1\) To evaluate safety and tolerability, we will conduct structured monitoring of adverse events (AEs) and serious AEs (SAEs). Additionally, we will perform safety laboratory tests including blood counts and chemistries, coagulation profile, physical exams, vital signs, and…
Inclusion Criteria: * Meets National Institute on Aging-Alzheimer's Association clinical diagnostic criteria for mild cognitive impairment (MCI) or AD dementia. * Has evidence of AD assessed by plasma p-tau217. Prior cerebrospinal fluid (CSF) or positron emission tomography (PET) amyloid testing (obtained clinically or through previous research) from the past 2 years may be used for eligibility with approval from study investigators. * Clinical Dementia Rating (CDR) global score of 0.5 or 1. * Mini-Mental State Exam (MMSE) score of 18 to 30 (inclusive). * 15-item Geriatric Depression Scale (G…
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 tablets.
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