Health TrialsbyHealthPanel

Sleep Trial to Prevent Alzheimer's Disease

ConditionsSleepAlzheimer Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suvorexant 20 mg

    Drug

    Suvorexant 20mg will be taken nightly for 24 months.

  • Placebo

    Drug

    Placebo will be taken nightly for 24 months.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Poor sleep treatment groupExperimental treatment 1 intervention
Group B: Poor sleep control gropPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
18-24 months

Secondary outcomes

1

Change in plasma Amyloid-β compared to placebo

Blood collection

Time frame
18-24 months
2

Change in CSF Amyloid-β compared to placebo

Cerebrospinal fluid collection

Time frame
18-24 months
3

Change in plasma tau compared to placebo

Blood collection

Time frame
18-24 months
4

Change in CSF tau compared to placebo

Cerebrospinal fluid collection

Time frame
18-24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Good Ventures

Collaborator

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
Apply now