BridgeMD
New treatment option for Alzheimer Disease, Early Onset
Official title Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD
ClinicalTrials.gov ID: NCT04500847
What this study is testing
What is Emtriva Capsule?
Emtriva Capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alzheimer disease, early onset.
Also referred to as Emtricitabine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- 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...
- 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
You likely can't join if
- Current medical or neurological condition that might impact cognition or performance on cognitive assessments, e.g., Huntington's disease...
- Brain MRI results showing findings unrelated to AD that, in the opinion of the investigator might be a leading cause of future cognitive decline...
- Score "yes" on item four or item five of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (eC-SSRS patient-reported...
- 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...
See the full eligibility 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...
- 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...
- Concurrent treatment with cholinesterase inhibitors and memantine are permitted on a stable dose for at least 60 days prior to baseline.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 people who are pregnant or currently breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.