Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD
Butler Hospital
Summary
This is a randomized, double-blind clinical trial of a daily oral dose of 200 mg emtricitabine vs. placebo in 35 participants with biomarker-confirmed MCI or mild to moderate dementia due to Alzheimer's disease. Study duration for each subject participating in the placebo-controlled research study will be approximately 12 months (up to a 3 months Screening Period, Baseline visit (1 month), 6 months of placebo or emtricitabine dosing, and 1 month follow-up). Participants will have up to 2 months to complete all procedures for the month 6 study visit.
Description
Alzheimer's disease (AD) is a devastating and increasingly frequent neurological disorder whose onset is strongly correlated with advanced age. Between 2000 and 2017 deaths from AD have increased 145%, and AD has become the 6th leading cause of death in the USA. Unfortunately, in spite of immense research and clinical efforts spanning several decades, cures have been elusive. This has prompted searches for new mechanisms of disease and new targets of therapy. One such direction is inflammation: aging and many age-associated diseases are believed to be causally linked with a chronic inflammator…
Eligibility
- Age range
- 50–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female, ages 50-85 years inclusive * Intellectually, visually and auditory capable, fluent in, and able to read, the language in which study assessments are administered (e.g. completion of at least six years of regular schooling or sustained employment or equivalent local level of knowledge). * Must meet NIA-AA research criteria for MCI and mild dementia due to AD * Mini Mental State Exam (MMSE) 15-30 inclusive * Clinical Dementia Rating (CDR) 0.5 - 2 * Must meet a cerebrospinal fluid (CSF) pTau/Aβ42 ratio of \> 0.024 * Participants must have an appropriate stud…
Interventions
- DrugEmtriva Capsule
200mg daily oral dose
- DrugPlacebo
200mg daily oral dose
Locations (2)
- Cedars-Sinai Medical CenterLos Angeles, California
- Memory and Aging Program, Butler HospitalProvidence, Rhode Island