Lemborexant for Alzheimer's Disease

Recruiting at 1 trial location

Overseen By Brendan P. Lucey, M.D.

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: Sedatives, Lemborexant interactors

Disqualifiers: Stroke, Renal impairment, Hepatic impairment, HIV/AIDS, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

201 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking sedating medications and any medications that interact with lemborexant if they cannot be discontinued. If you are on such medications, you may need to stop them to participate in the study.

What is the purpose of this trial?

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.

Research Team

Brendan Lucey, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for individuals aged 65 or older with early-stage Alzheimer's disease (Global Clinical Dementia Rating of 0) who can consent to study procedures. They must not have sleep disorders, severe liver or kidney issues, untreated sleep apnea, a high risk of stroke, recent substance abuse, or be on certain medications that interact with lemborexant.

Inclusion Criteria

Any race or ethnicity

I am either male or female.

Willing and able to undergo study procedures

Exclusion Criteria

STOP-Bang score ≥ 6

Body mass index >35

History of substance abuse or alcoholism in the preceding 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lemborexant or placebo once a night for 6 months to assess its effect on Alzheimer's disease biomarkers

6 months

Monthly visits for monitoring and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Lemborexant

Trial Overview The trial tests if lemborexant, a sleep aid at doses of either 10 mg or 20 mg, affects the levels of amyloid-beta and tau proteins in cerebrospinal fluid compared to a placebo. These proteins are associated with the development of Alzheimer's disease.

Participant Groups

Group I: Lemborexant 20 mg Experimental Treatment 1 Intervention

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

Group II: Lemborexant 10 mg Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

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.

Lemborexant is already approved in United States, Canada, Japan for the following indications:

Approved in United States as Dayvigo for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults

Approved in Canada as Dayvigo for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance, with or without associated impairment in daily functioning

Approved in Japan as Dayvigo for:

• Treatment of insomnia

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University