Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau

Alzheimer Disease Clinical Trial

Official title:

Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05728736
• Other study ID #: HRPO 202210049
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 1, 2023
• Est. completion date: October 4, 2023

Study information

• Verified date: November 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 4, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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, tobacco or marijuana 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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Lemborexant 25 mg
Lemborexant 25mg will be taken nightly for two consecutive nights.
• Placebo
Placebo will be taken nightly for two consecutive nights

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Brendan Lucey	Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CNS tau phosphorylation	Changes in CSF pT181/T181 ratio compared to placebo	48 hours
Secondary	Changes in other CSF AD biomarkers	Changes in CSF pS202/S202, pT217/T217, and amyloid-beta	48 hours