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DORA and LP in Alzheimer's Disease Biomarkers

NCT06274528 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lemborexant 10 mg

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

DRUG

Lemborexant 20mg

20 mg; capsule; QD; 6 month duration

DRUG

Placebo

0 mg; capsule; QD; 6 month duration

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eisai Inc.

    collaborator INDUSTRY

  • National Institute on Aging (NIA)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Brendan Lucey, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2030-03-31
Completion
2030-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06274528 on ClinicalTrials.gov