This is a Phase I randomized, double-blind study seeking to enroll 35 participants with mild cognitive impairment (MCI) or mild to moderate Alzheimer’s disease (AD). The study will last approximately 9 months and includes a screening, treatment and follow-up phase. Participants will be randomly assigned to receive either Emtricitabine or a placebo, which is an inactive substance designed to look like a medication, but has no effect. Both Emtricitabine and the placebo will be administered as a daily oral dose. Participants will be asked to come to Butler Hospital or Brown University MRI Research Facility during the study.
This trial is supported by a grant from the Alzheimer’s Association’s Part the Cloud Translational Research Funding program, which aims to increase funding for early-stage clinical trials of promising new drug treatments.
The purpose of this study is to look at the safety and tolerability of Emtricitabine (FTC, Emtriva©, Gilead) in treating participants with MCI or mild to moderate AD. It will specifically examine inflammation in the brain due to AD and see if Emtricitabine could potentially reduce the inflammation at a level that could help with cognition and daily function.
Emtricitabine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). This type of drug is already approved by the FDA to treat AIDS (Acquired Immune Deficiency Syndrome) caused by infection with HIV (Human Immunodeficiency Virus).
Men and women aged 50-85 with mild cognitive impairment (MCI) or mild to moderate Alzheimer’s disease. Interested individuals can learn more about their eligibility by contacting the Memory and Aging Program Outreach Team at 401-455-6402 or by sending an email to memory@butler.org.