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WithdrawnPhase 2

Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau

Lead sponsor

Brendan Lucey

Asset

Lemborexant

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Amyloid biomarker required (plasma)•MMSE ≥27

Primary endpoint

•CNS tau phosphorylation

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 IDHRPO 202210049

NCT IDNCT05728736

Timeline

Milestones

Study first posted2023-02-15actual

Study start2023-03-01actual

Primary completion2023-09-27actual

Study completion2023-10-04actual

Last update posted2023-11-08actual

Assets

Drug assets

Lemborexant

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Age 60-80 years

•Any sex

•Any race/ethnicity

•Mini-Mental Status Examination score (MMSE) ≥ 27

•Positive plasma amyloid-beta test (i.e., amyloid-positive)

•Pittsburgh Sleep Quality Index >5

Exclusion criteria

•Cognitive impairment as determined by history of MMSE < 27

•Inability to speak or understand English

•Any sleep disorders other than insomnia

•No history of moderate-to-severe sleep-disordered breathing and STOP-Bang score > 5

•History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders

•No more than mild sleep apnea (AHI <16) on PSG

•Sleep schedule outside the range of bedtime 22:00-midnight

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

•Cardiovascular disease requiring medication except for controlled hypertension (PI discretion)

•Stroke

•Hepatic or renal impairment

•Pulmonary disease (PI discretion)

•Type 1 diabetes

•HIV or AIDS

•Neurologic or psychiatric disorder requiring medication (PI discretion)

•Suicidal ideations

•Alcohol, tobacco or marijuana use (PI discretion)

•Use of sedating medications (PI discretion)

•Inability to get out of bed independently

•In the opinion of the investigator, the participant should be excluded due to an abnormal physical examination.

•Current pregnancy

•Body Mass Index >35

•History of migraines (PI discretion)

•History of drug abuse in the last 6 months

•History or presence of any clinically significant medical condition, behavioral or psychiatric disorder (including suicidal ideation), or surgical history based on medical record or patient report that could affect the safety of the subject or interfere with study assessments or in the judgment of the PI participant is not a good candidate.

•Urinary or fecal incontinence

•Concurrently enrolled in another trial of an investigational drug or device

Endpoints (2)

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

Amyloid biomarkers

Fluid / digital biomarkers

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Changes in other CSF AD biomarkers

Time frame:48 hours

descriptive

Fluid / digital biomarkers

1 endpoint

Primary/protocol endpoint

Change in CNS tau phosphorylation

Time frame:48 hours

change from baseline, improvement

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.