Sleep Trial to Prevent Alzheimer's Disease

NCT04629547 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202008007
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Alzheimer Disease

Keywords

poor sleep; Amyloid-Beta; Insomnia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo

  Blood collection

  18-24 months

Secondary Outcomes (11)

• 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

Study Arms (2)

Poor sleep treatment group

EXPERIMENTAL

100 participants will be randomized to take suvorexant 20mg daily at h.s. for 18-24 months

Drug: Suvorexant 20 mg

Poor sleep control grop

PLACEBO COMPARATOR

100 participants will be randomized to take placebo daily at h.s. for 18-24 months

Drug: Placebo

Interventions

Suvorexant 20 mg DRUG

Suvorexant 20mg will be taken nightly for 24 months.

Also known as: Belsomra

Poor sleep treatment group

Placebo DRUG

Placebo will be taken nightly for 24 months.

Also known as: inactive pill, sugar pill

Poor sleep control grop

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female.
• Any race or ethnicity.
• Participants must be age ≥65 years and able to sign informed consent.
• Global Clinical Dementia Rating (CDR) 0.
• Willing and able to undergo study procedures.

You may not qualify if:

• 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
• Stroke.
• Chronic kidney disease defined as patients with markers of kidney damage or eGFR of \< 45 ml/min/1.73m2.
• 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.
• Regular alcohol consumption 3 or more days a week over the last 6 months. Regular alcohol consumption is defined as having more than 2 alcoholic beverages within 3 hours of bedtime. Participants that agree to reduce alcohol consumption during the study may not be excluded.
• History of presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or participant report that could affect the safety of the participant or interfere with study assessments or in the judgement of the Principal-Investigator (PI) if participant is not a good candidate.
• Cardiovascular disease requiring medication except for controlled hypertension.
• Pulmonary disease.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Good Ventures: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Plaque, Amyloid; Sleep Initiation and Maintenance Disorders

Interventions

suvorexant; Sugars

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Brendan Lucey, MD

  Washington Univeristy School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Toedebusch, BS

CONTACT

3147470646; toedebuschc@wustl.edu

Chloe Meehan, MA

CONTACT

3142730878; cmeehan@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Sleep Medicine Section Head

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 16, 2020
• Study Start: May 25, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)