Actively Recruiting
Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD
Led by Butler Hospital · Updated on 2025-05-04
35
Participants Needed
2
Research Sites
223 weeks
Total Duration
On this page
Sponsors
B
Butler Hospital
Lead Sponsor
A
Alzheimer's Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, ages 50-85 years inclusive
- Able to understand, speak, and read the study language fluently
- Diagnosis meeting NIA-AA criteria for mild cognitive impairment or mild dementia due to Alzheimer's disease
- Mini Mental State Exam (MMSE) score between 15 and 30 inclusive
- Clinical Dementia Rating (CDR) score between 0.5 and 2
- Cerebrospinal fluid pTau/A2 ratio greater than 0.024
- Have a study partner who can participate and accompany to visits
- Stable dose of cholinesterase inhibitors and memantine for at least 60 days prior to baseline allowed
You will not qualify if you...
- Medical or neurological conditions affecting cognition or test performance, such as Huntington's, Parkinson's, schizophrenia, bipolar disorder, major depression, ADD/ADHD, multiple sclerosis, ALS, seizure disorder, substance abuse or dependence within 2 years, or traumatic brain injury with ongoing neurological symptoms
- Brain MRI findings unrelated to Alzheimer's that may impact cognition or safety
- Recent suicidal ideation or behavior as assessed by Columbia Suicide Severity Rating Scale
- Use of investigational drugs within defined washout periods
- Use of drugs known for major organ toxicity within 4 weeks prior to randomization
- Positive drug screen indicating abuse or dependence
- Significant abnormal ECG findings
- Contraindications to lumbar puncture
- Positive test for hepatitis or HIV infection
- Severe kidney or liver impairment
- Significant heart disease including recent heart attack, heart failure, or unstable angina
- Pregnancy or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Memory and Aging Program, Butler Hospital
Providence, Rhode Island, United States, 02906
Actively Recruiting
Research Team
M
Meghan Riddle, MD
CONTACT
J
Joslynn Faustino, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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