Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD

Part of paid clinical trials in Los Angeles, California.

Sponsor
Butler Hospital
Study ID
NCT04500847
Phase
PHASE1
Status
Recruiting
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Conditions

  • Alzheimer Disease, Early Onset
  • Mild Cognitive Impairment
  • Moderate Dementia

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Emtriva Capsule — DRUG
    200mg daily oral dose
  • Placebo — DRUG
    200mg daily oral dose

Study Details

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.

Key Dates

Start date
Dec 17, 2021
Status verified
Aug 2024
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1
    25 MCI and mild to moderate AD subjects
  • Placebo Comparator: Group 2
    10 MCI and mild to moderate AD subjects

Primary Outcome Measure

Number of participants with treatment emergent adverse events (TEAE's) in the treatment group will be compared to the placebo group [ Time Frame: Baseline to the follow up study visit (7-8 months after first treatment) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Sandra Gomez, MD
[email protected]
(424) 315-1224
Sara Espinoza, MD (PRINCIPAL_INVESTIGATOR)
Nicolas Musi, MD (SUB_INVESTIGATOR)
Memory and Aging Program, Butler HospitalProvidenceRhode Island02906
Meghan Riddle, MD
[email protected]
401 455-6403
Denise Jerue, RN
[email protected]
401 455-6403

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By research site
Cedars-Sinai Medical Center· Los Angeles, CAMemory and Aging Program, Butler Hospital· Providence, RI

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