Trials / Completed
CompletedNCT02045056
Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Gregory Jicha, 323-5550 · Academic / Other
- Sex
- All
- Age
- 65 Years – 90 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the safety and efficacy of gemfibrozil in modulating microRNA-107 levels for the prevention of Alzheimer's disease in subjects with intact cognition and mild cognitive impairment
Detailed description
Double-blind, placebo controlled, parallel-design. 48 cognitively-intact subjects, and 24 subjects with early cognitive decline (CDR 0.5) will be randomly assigned to treatment with gemfibrozil (600 mg orally twice a day) or placebo for 52 weeks. Safety assessments will include routine assessment of adverse events, safety labs, and brain magnetic resonance imaging.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemfibrozil | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2018-06-30
- Completion
- 2019-06-01
- First posted
- 2014-01-24
- Last updated
- 2019-10-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02045056. Inclusion in this directory is not an endorsement.