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Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau

Sponsor
Brendan Lucey (Other)
Overall Status
Recruiting
CT.gov ID
NCT05728736
Collaborator
Eisai Inc. (Industry)
30
Enrollment
1
Location
2
Arms
23
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will look at the effects of lemborexant on Alzheimer's disease biomarkers found in the cerebrospinal fluid (CSF) and blood in individuals who are poor sleepers

Condition or Disease Intervention/Treatment Phase
  • Drug: Lemborexant 25 mg
  • Drug: Placebo
 Phase 2

Detailed Description

This study will determine the acute effect of lemborexant on CNS tau phosphorylation and other Alzheimer's disease biomarkers in individuals with poor sleep quality.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment

20 participants will be randomized to take lemborexant 25mg at h.s for two consecutive nights

Drug: Lemborexant 25 mg
Lemborexant 25mg will be taken nightly for two consecutive nights.
Other Names:
  • Dayvigo

    		•
    Placebo Comparator: placebo

    10 participants will be randomized to take placebo at h.s. for two consecutive nights.

    Drug: Placebo
    Placebo will be taken nightly for two consecutive nights
    Other Names:
  • inactive pill
  • sugar pil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in CNS tau phosphorylation [48 hours]

      Changes in CSF pT181/T181 ratio compared to placebo

    Secondary Outcome Measures

    1. Changes in other CSF AD biomarkers [48 hours]

      Changes in CSF pS202/S202, pT217/T217, and amyloid-beta

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 or tobacco 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Brendan Lucey
    • Eisai Inc.

    Investigators

    • Principal Investigator: Brendan Lucey, MD, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brendan Lucey, Principal Investigator, Sleep Medicine Section Head, Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT05728736
    Other Study ID Numbers:
    • HRPO 202210049
    First Posted:
    Feb 15, 2023
    Last Update Posted:
    Feb 21, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Brendan Lucey, Principal Investigator, Sleep Medicine Section Head, Washington University School of Medicine
    poor sleep
    Additional relevant MeSH terms:
    Alzheimer Disease
    Lemborexant

    Study Results

    No Results Posted as of Feb 21, 2023