NCT06274528

Brief Summary

The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the blood. Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for phase_2 alzheimer-disease

Timeline
46mo left

Started Mar 2024

Longer than P75 for phase_2 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Mar 2024Mar 2030

First Submitted

Initial submission to the registry

January 29, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

6.1 years

First QC Date

January 29, 2024

Last Update Submit

April 29, 2026

Conditions

Alzheimer Disease

Keywords

SleepOlder AdultsDORA

Outcome Measures

Primary Outcomes (1)

  • Changes plasma pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo

    plasma collection

    6 months

Secondary Outcomes (6)

  • Number of participants with treatment-related adverse events

    6 months

  • Measure the blood concentration of lemborexant 10 mg and 20 mg and determine the dose-response relationship with CSF pT181/T181

    6 months

  • Measure changes on blood plasma amyloid-beta isoforms (Aβ38, Aβ40, Aβ42, Aβ42/Aβ40)

    6 months

  • Measure changes of CSF amyloid beta isoforms (Aβ38, Aβ40, Aβ42,Aβ42/Aβ40 )

    6 months

  • Measure changes of blood plasma p-tau/tau forms (T181, pT181, pT181/T181, S202, pS202, pS202/S202, T217, pT217, pT217/T217).

    6 months

  • +1 more secondary outcomes

Other Outcomes (4)

  • Measure changes of cerebrospinal TREM2 (exploratory)

    6 months

  • Measure changes of cerebrospinal NPTX2 (exploratory)

    6 months

  • Measure changes of cerebrospinal NfL (exploratory)

    6 months

  • +1 more other outcomes

Study Arms (3)

Lemborexant 10 mg

EXPERIMENTAL

Lemborexant is a capsule, taken by mouth once a night, approximately 30 minutes prior to bed for 6 months.

Drug: Lemborexant 10 mg

Lemborexant 20 mg

EXPERIMENTAL

Lemborexant is a capsule, taken by mouth once a night, approximately 30 minutes prior to bed for 6 months.

Drug: Lemborexant 20mg

Placebo

PLACEBO COMPARATOR

Placebo is in capsule form and contains an inactive substance. It is taken by mouth once a night, approximately 30 minutes prior to bed for 6 months.

Drug: Placebo

Interventions

Lemborexant 10 mgDRUG

Within FDA approved dose 10 mg; capsule; QD, 6 month duration

Also known as: DAYVIGO
Lemborexant 10 mg
Lemborexant 20mgDRUG

20 mg; capsule; QD; 6 month duration

Also known as: DAYVIGO
Lemborexant 20 mg
PlaceboDRUG

0 mg; capsule; QD; 6 month duration

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder 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 or reported symptoms suggestive of restless legs syndrome, narcolepsy, or parasomnia.
  • STOP-Bang score \>6 for participants without PAP.
  • Untreated sleep apnea AHI\>15
  • Poorly treated sleep apnea due to noncompliance or an AHI ≥ 10.
  • \- PAP compliance is defined as ≥ 4 hours per night \>70% of the nights.
  • Plasma p-Tau217/np-Tau217% \<2.5
  • Stroke.
  • History of renal impairment
  • Defined as older adult patients with markers of kidney damage or eGFR \< 45.0 ml/min/1.73m2.
  • Normal Limits ≥ 45.0 mL/min/1.73m2
  • History of hepatic impairment
  • AST and/or ALT ≥ 2X upper limit of normal (ULN).
  • Normal Limits: AST 11-47 IU/L and ALT 6-53 IU/L
  • HIV/AIDS.
  • History of substance abuse or alcohol abuse in the preceding 6 months.
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis, School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

lemborexant

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Brendan Lucey, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe Meehan, MA

CONTACT

314-273-0878cmeehan@wustl.edu

Crirstina Toedebusch

CONTACT

314-747-0646toedebuschc@wustl.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Pharmacist
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 23, 2024

Study Start

March 11, 2024

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

US(1)