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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 is a Phase 1 study that has completed, run by Case Western Reserve University. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03706885
The ClinicalTrials.gov registry entry for NCT03706885 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Western Reserve University, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sustiva Pill is the first listed.
NCT03706885 reports 0 study locations.
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.
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