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Lemborexant 20 mg for Alzheimer's Disease

Phase 2

Recruiting

Led By Brendan Lucey, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be age ≥ 65 years and able to sign informed consent

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial aims to investigate whether the sleep aid, lemborexant, can reduce the levels of harmful proteins (amyloid-beta and tau) in the fluid surrounding the brain, which are linked

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Lemborexant may cause side effects like drowsiness during daytime, headaches, abnormal dreams or nightmares; it might also lead to falls due to sudden muscle weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 65 years or older and can give my consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

Measure changes of cerebrospinal fluid p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217).

+3 more

Other outcome measures

Measure changes of blood plasma NfL (exploratory)

Measure changes of cerebrospinal NPTX2 (exploratory)

Measure changes of cerebrospinal NfL (exploratory)

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Lemborexant 20 mgExperimental Treatment1 Intervention

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

Group II: Lemborexant 10 mgExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lemborexant 10 mg

2014

Completed Phase 3

~400

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,501 Total Patients Enrolled

Brendan Lucey, MDPrincipal InvestigatorWashington University School of Medicine

4 Previous Clinical Trials

284 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall participant count in this clinical study?

"Indeed, the details on clinicaltrials.gov highlight that this particular research study is actively seeking eligible individuals. The trial was initially disclosed on March 1st, 2024 and last amended on February 15th, 2024. A total of 201 participants are sought from a single designated site."

Answered by AI

Is the enrollment process currently ongoing for individuals interested in participating in this trial?

"Indeed, the details on clinicaltrials.gov highlight that this investigation is currently in search of suitable participants. The trial was initially uploaded on March 1st, 2024 and underwent its most recent revision on February 15th, 2024. This study aims to enroll a total of 201 subjects at one designated site."

Answered by AI