Recruiting

Phase 1

NRTIsRepurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD

Sponsor:

Butler Hospital

Code:

NCT04500847

Conditions

Alzheimer Disease, Early Onset

Mild Cognitive Impairment

Moderate Dementia

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Emtriva Capsule

Placebo

Study Details

Brief 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.

Conditions

Alzheimer Disease, Early Onset

Mild Cognitive Impairment

Moderate Dementia

Study ID

NCT04500847

Start date

Dec 17, 2021

Status verified date

Aug, 2024

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 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 Criteria:

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.

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Emtriva Capsule

200mg daily oral dose

Placebo

200mg daily oral dose

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 and Locations

Central contacts

Meghan Riddle, MD

(401) 455-6403 MRiddle@butler.org

Joslynn Faustino, PhD

(401) 455-6403 JFaustino@butler.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Sandra Gomez, MD

(424) 315-1224 Sandra.Gomez3@cshs.org

Principal Investigator:

Sara Espinoza, MD

Memory and Aging Program, Butler Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Meghan Riddle, MD

401 455-6403 MRiddle@butler.org

Denise Jerue, RN

401 455-6403 DJerue@butler.org

More Information

Sponsor

Butler Hospital

Last update posted

May 4, 2025

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Butler Hospital on 2025-05-04.