NCT04629547

Sleep Trial to Prevent Alzheimer's Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Suvorexant 20 mg	Suvorexant 20mg will be taken nightly for 24 months.
DRUG	Placebo	Placebo will be taken nightly for 24 months.

Timeline

• Start date: 2022-05-25
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2020-11-16
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study