Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau

NCT05728736 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: HRPO 202210049
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Alzheimer Disease

Keywords

poor sleep

Outcome Measures

Primary Outcomes (1)

• Change in CNS tau phosphorylation

  Changes in CSF pT181/T181 ratio compared to placebo

  48 hours

Secondary Outcomes (1)

• Changes in other CSF AD biomarkers

  48 hours

Study Arms (2)

treatment

EXPERIMENTAL

20 participants will be randomized to take lemborexant 25mg at h.s for two consecutive nights

Drug: Lemborexant 25 mg

placebo

PLACEBO COMPARATOR

10 participants will be randomized to take placebo at h.s. for two consecutive nights.

Drug: Placebo

Interventions

Lemborexant 25 mg DRUG

Lemborexant 25mg will be taken nightly for two consecutive nights.

Also known as: Dayvigo

treatment

Placebo DRUG

Placebo will be taken nightly for two consecutive nights

Also known as: inactive pill, sugar pil

placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brendan Lucey: lead
• Eisai Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Brendan Lucey, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Sleep Medicine Section Head

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 15, 2023
• Study Start: March 1, 2023
• Primary Completion: September 27, 2023
• Study Completion: October 4, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

US (1)