Sleep Trial to Prevent Alzheimer's Disease
Part of paid clinical trials in St Louis, Missouri.
- Sponsor
- Washington University School of Medicine
- Study ID
- NCT04629547
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Alzheimer Disease
- Sleep
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Suvorexant 20 mg — DRUGSuvorexant 20mg will be taken nightly for 24 months.
- Placebo — DRUGPlacebo will be taken nightly for 24 months.
Study Details
The purpose of this study is to determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain.
Key Dates
- Start date
- May 25, 2022
- Status verified
- Dec 2025
- Primary completion
- May 31, 2026
- Completion
- May 31, 2026
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Poor sleep treatment group100 participants will be randomized to take suvorexant 20mg daily at h.s. for 18-24 months
- Placebo Comparator: Poor sleep control grop100 participants will be randomized to take placebo daily at h.s. for 18-24 months
Primary Outcome Measure
Change from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo [ Time Frame: 18-24 months ]
Central Contacts
- Cristina Toedebusch, BS3147470646
- Chloe Meehan, MA3142730878
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | Brendan Lucey, MD (PRINCIPAL_INVESTIGATOR) |
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