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

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Suvorexant 20 mg — DRUG
    Suvorexant 20mg will be taken nightly for 24 months.
  • Placebo — DRUG
    Placebo 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 group
    100 participants will be randomized to take suvorexant 20mg daily at h.s. for 18-24 months
  • Placebo Comparator: Poor sleep control grop
    100 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

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Cristina Toedebusch, BS
13147470646
Brendan Lucey, MD (PRINCIPAL_INVESTIGATOR)

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