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NCT03706885 · ClinicalTrials.gov registry record · Phase 1
Efavirenz for Patients With Alzheimer's Disease
A Phase 1 study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT03706885: Completed Phase 1 study, sponsored by Case Western Reserve University.
NCT03706885 is a Phase 1 study that has completed, run by Case Western Reserve University. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03706885, a Phase 1 study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This will be a two-center, placebo controlled blinded clinical trial to evaluate the safety and tolerability of efavirenz (EFV) in 36 clinically stable subjects with mild cognitive impairment/early dementia due to Alzheimer's Disease (AD) age ≥55 years. Of these 36 total subjects, 18 will be recruited by MGH and 18 will be recruited by UH. A subset of the subjects at MGH only will also participate in a Stable Isotope Labeling Kinetics (SILK) protocol with deuterated water (a nonhazardous substance), designed to more precisely measure EFV effects on CNS cholesterol turnover. Each respective site's 18 total recruited individuals will be divided into 3 groups: these 3 groups will represent two particular dosages of EFV and a placebo group, respectively. In a double-blind fashion, participants will be receiving either a capsule of EFV or placebo daily for 20 weeks. At MGH only, 12 individuals (4 from each of the two EFV groups and placebo) will participate in the unique "heavy water" SILK protocol assessing the kinetics of deuterium enrichment in plasma 24-hydroxycholesterol (24-OHC). All study participants at both sites will have their blood, cerebral spinal fluid, and urine analyzed at various points throughout the study. All participants will have their DNA genotyped for APOE isoforms (E2, E3 or E4) and single nucleotide polymorphisms (SNPs) in CYP46A1 (rs754203) and CYP2B6 (rs3745274) to be used for post-hoc analysis.
Primary Outcome
Changes in plasma 24-hydroxycholesterol (measured in ng/dL) by more or equal to 30%.
Interventions
- DRUG Sustiva Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-05-05 |
| Est. Completion | 2022-01-28 |
| Phase | Phase 1 |
What the finished NCT03706885 record still lists
NCT03706885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Sustiva Pill is the first listed.
NCT03706885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03706885 about?
NCT03706885 is a clinical study titled "Efavirenz for Patients With Alzheimer's Disease". This will be a two-center, placebo controlled blinded clinical trial to evaluate the safety and tolerability of efavirenz (EFV) in 36 clinically stable subjects with mild cognitive impairment/early dementia due to Alzheimer's Disease (AD) age ≥55 years. Of these 36 total subjects, 18 will be recruit...
What is the current status of trial NCT03706885?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2018-05-05. Estimated completion is 2022-01-28.
What interventions are being tested in trial NCT03706885?
The interventions under investigation include: Sustiva Pill (DRUG).
Who is sponsoring clinical trial NCT03706885?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03706885's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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