Sleep Trial to Prevent Alzheimer's Disease
Overview
- Phase
- Phase 2
- Intervention
- Suvorexant 20 mg
- Conditions
- Sleep
- Sponsor
- Washington University School of Medicine
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
This study will investigate if long-term treatment with suvorexant will slow amyloid-β accumulation in the brain. Amyloid-β is a protein involved in the disease process leading to Alzheimer's disease. This study will evaluate if suvorexant can decrease the amount of amyloid-beta detected by plasma pT217/T217.
Investigators
Brendan Lucey
Principal Investigator, Sleep Medicine Section Head
Washington University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Male or female.
- •Any race or ethnicity.
- •Participants must be age ≥65 years and able to sign informed consent.
- •Global Clinical Dementia Rating (CDR)
- •Willing and able to undergo study procedures.
Exclusion Criteria
- •History of reported symptoms suggestive of restless legs syndrome, narcolepsy or other central disorder of hypersomnolence, or parasomnia
- •STOP-Bang score \>6 for participants without PAP
- •Untreated OSA with AHI ≥15 on home sleep test
- •Treated sleep apnea with PAP non-compliance
- •PAP compliance is defined as \>= 4 hours per night \>70% of the nights
- •Plasma A-beta and tau test with a plasma p-tau 217% ≤ 1.19
- •Chronic kidney disease defined as patients with markers of kidney damage or eGFR of \< 45 ml/min/1.73m
- •Hepatic impairment defined as AST and/or ALT \> 2x upper limit of normal (normal limits AST: 11-47 IU/L, ALT: 6-53 IU/L).
- •HIV/AIDS.
- •History of substance abuse or alcohol abuse in the proceeding 6 months.
Arms & Interventions
Poor sleep treatment group
100 participants will be randomized to take suvorexant 20mg daily at h.s. for 18-24 months
Intervention: Suvorexant 20 mg
Poor sleep control grop
100 participants will be randomized to take placebo daily at h.s. for 18-24 months
Intervention: Placebo
Outcomes
Primary Outcomes
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
Blood collection
Secondary Outcomes
- Change in plasma Amyloid-β compared to placebo(18-24 months)
- Change in CSF Amyloid-β compared to placebo(18-24 months)
- Change in plasma tau compared to placebo(18-24 months)
- Change in CSF tau compared to placebo(18-24 months)
- Change in plasma p-tau compared to placebo(18-24 months)
- Change in CSF p-tau compared to placebo(18-24 months)
- Change in cognitive performance compared to placebo(18-24 months)
- Change in transcriptomics compared to placebo(18-24 months)
- Change in metabolomics compared to placebo(18-24 months)
- Change in proteomics compared to placebo(18-24 months)
- Change in gut microbiome compared to placebo(18-24 months)