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RecruitingPhase 2

Sleep Trial to Prevent Alzheimer's Disease

Asset

Suvorexant

Listed sites

1

Recruiting sites

1

Enrollment

120

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥65

Primary endpoint

•Amyloid-β accumulation

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID202008007
NCT IDNCT04629547

Timeline

Milestones

Study first posted2020-11-16actual
Study start2022-05-25actual
Last update posted2026-07-13actual
Primary completion2028-05estimated (month precision)
Study completion2028-05estimated (month precision)

Assets

Drug assets

Suvorexant

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
SexAll
Healthy volunteersAccepted

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) 0.
•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
•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.
•Has any medical condition that, in the PI's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data. Potential medical conditions that will be exclusionary at the PI's discretion:
-Cardiovascular disease requiring medication except for controlled hypertension.
-Pulmonary disease.
-Type I diabetes.
-Neurologic or psychiatric disorder requiring medication.
-Tobacco use.
-Use of sedating medications.
-Use of medications that interact with suvorexant (if cannot be discontinued)
-Abnormal safety labs
•History of current suicidal ideations.
•Currently pregnant or breast-feeding.
•In the opinion of the PI, the participant should be excluded due to an abnormal physical examination.
•Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment.
•Must not participate in another drug or device study prior to the end of this study participation.

Exclusion criteria for optional lumbar punctures

-• Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Fluid / digital biomarkers
4
Amyloid biomarkers
3
Tau biomarkers
2
Other (unclassified)
2
Global cognition
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Change in cognitive performance compared to placebo

Time frame:18-24 months

change from baseline, improvement

Amyloid biomarkers

3 endpoints
Primary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

Change in plasma Amyloid-β compared to placebo

Time frame:18-24 months

change from baseline, improvement

Secondary/protocol endpoint

Change in CSF Amyloid-β compared to placebo

Time frame:18-24 months

change from baseline, improvement

Tau biomarkers

2 endpoints
Secondary/protocol endpoint

Change in plasma p-tau compared to placebo

Time frame:18-24 months

change from baseline, improvement

Secondary/protocol endpoint

Change in CSF p-tau compared to placebo

Time frame:18-24 months

change from baseline, improvement

Fluid / digital biomarkers

4 endpoints
Secondary/protocol endpoint

Change in CSF tau compared to placebo

Time frame:18-24 months

change from baseline, improvement

Secondary/protocol endpoint

Change in transcriptomics compared to placebo

Time frame:18-24 months

change from baseline, improvement

Secondary/protocol endpoint

Change in metabolomics compared to placebo

Time frame:18-24 months

change from baseline, improvement

Secondary/protocol endpoint

Change in proteomics compared to placebo

Time frame:18-24 months

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change in plasma tau compared to placebo

Time frame:18-24 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in gut microbiome compared to placebo

Time frame:18-24 months

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.