Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-85
SponsorButler Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Current medical or neurological condition that might impact cognition or performance on cognitive assessments, e.g., Huntington's disease, Parkinson's disease, syphilis, schizophrenia, bipolar disorder, active major depression, attention deficit/ hyperactivity disorder (ADD/ADHD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), active seizure disorder, current alcohol/drug abuse or dependence, or dependence within the last two years, or history of traumatic brain injury associated with loss of consciousness and ongoing residual transient or permanent neurological signs/symptoms including cognitive deficits, and/or associated with skull fracture

Brain MRI results showing findings unrelated to AD that, in the opinion of the investigator might be a leading cause of future cognitive decline, might pose a risk to the participant, or might confound MRI assessment for safety monitoring

Score "yes" on item four or item five of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (eC-SSRS patient-reported outcome), if this ideation occurred in the past six months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item is included in the Suicidal Behavior section), if this behavior occurred in the past 2 years prior to screening

Small molecules: after five half-lives, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer

Trial design

Treatments tested in this trial

  • Emtriva Capsule
  • Placebo

Treatment groups

35 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Butler Hospital

Lead sponsor

Alzheimer's Association

Collaborator

Brown University

Collaborator

The Miriam Hospital

Collaborator

Cedars Sinai Medical Center, Los Angeles, USA

Collaborator