Repurposing HIV Drugs for Alzheimer's Disease
This study is testing if a drug called emtricitabine (Emtriva Capsule), which is typically used for HIV, can help people with early Alzheimer's disease (AD) or mild to moderate dementia. Researchers believe that by reducing inflammation in the brain, emtricitabine might slow down the disease. You would receive either a 200mg daily oral dose of emtricitabine or a placebo (an inactive pill). The study aims to enroll 35 participants between 50 and 85 years old who have been diagnosed with mild cognitive impairment (MCI) or mild to moderate dementia due to Alzheimer's disease, confirmed by biomarkers. The main goal is to compare any side effects between the emtricitabine and placebo groups over about 7-8 months. The current recruitment status is unclear.
- Study design
- This is a randomized, double-blind study, meaning participants are randomly assigned to receive either the active drug or placebo, and neither you nor the study staff will know which you are receiving. It plans to enroll 35 participants.
- What's involved
- Your participation would last approximately 12 months, including up to 3 months for screening, a baseline visit, 6 months of taking the study drug or placebo daily, and a 1-month follow-up. You would have up to 2 months to complete all procedures for the 6-month visit.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed up for about 7-8 months after starting treatment to monitor for side effects.
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NCT04500847
Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD
UNKNOWN
PHASE1Ages 50–85InterventionalTreatmentButler HospitalInvestigator-initiated
~35 participants
Updated 2025-05-04 on ClinicalTrials.gov
What's tested:Emtriva CapsulePlacebo
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment emergent adverse events (TEAE's) in the treatment group will be compared to the placebo group
Measured over Baseline to the follow up study visit (7-8 months after first treatment)
Conditions
Where it's being run
2 sites across 2 statesCalifornia1
Rhode Island1
Study leadership
- Meghan Riddle, MD · PRINCIPAL_INVESTIGATOR · Butler Hospital
- John Sedivy, PhD · PRINCIPAL_INVESTIGATOR · Brown University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 study partner who agrees to participate in the study and who is intellectually, visually, and auditory capable, and fluent in, and able to read, the language in which study assessments are administered. Additionally, the study partner must be capable of and willing to: Accompany the participant to visits that requires the input of the study partner
Concurrent treatment with cholinesterase inhibitors and memantine are permitted on a stable dose for at least 60 days prior to baseline.
Exclusion
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
Use of other investigational drugs prior to screening until:
Small molecules: after five half-lives, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer
Biologicals: blood concentration has returned to baseline (or below serological responder threshold) for antibodies induced by active immunotherapy; or five half- lives for monoclonal antibodies or other biologicals
Approximately four weeks prior to randomization, the use of any drug or treatment known for the potential to cause major organ system toxicity, i.e. drugs that may require periodic safety monitoring of a specific organ or body fluid. Examples include, but are not limited to clozapine, cancer medical treatment like tamoxifen, systemic immunosuppressive drugs like methotrexate or interferon, or other immunosuppressive biological medicines for rheumatic diseases or multiple sclerosis
A positive drug screen, if, in the investigator's opinion, this is due to drug abuse or dependence.
Significant ECG findings that are assessed as clinically significant by the investigator (e.g. sustained ventricular tachycardia, significant second or third degree atrioventricular block without a pacemaker, long QT syndrome or clinically meaningful prolonged QT interval).
Contraindication to lumbar puncture including use of anti-coagulants, low platelet count, history of back surgery (with the exception of microdiscectomy or laminectomy over one level), signs or symptoms of intracranial pressure, spinal deformities or other spinal conditions that in the judgment of the investigator would preclude a lumbar puncture
History of or active hepatitis or HIV infection (based on a positive lab result for HBV and/or HIV, to be performed during screening
Severe renal impairment
Severe hepatic impairment
Significant cardiac disease including recent (within six months) myocardial infarction, congestive heart failure or unstable angina
Female subjects who are pregnant or currently breastfeeding.
What this trial measures
- Number of participants with treatment emergent adverse events (TEAE's) in the treatment group will be compared to the placebo groupBaseline to the follow up study visit (7-8 months after first treatment)
Number of participants with treatment emergent adverse events and serious adverse events as assessed by CTCAE (Version 4.03).