Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial

NCT06093126 | Recruiting Phase 4 FDA Drug

• 1 other identifier: LembN01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Insomnia is a highly common, chronic disorder that is distressful for the patient but also for caregivers and can give rise to a heavy burden on the healthcare team. Sleeping aids like benzodiazepines and other sedatives (e.g., zolpidem, zopiclone) have been widely used to help treat insomnia. However, sleeping aids are also known to cause adverse drug reactions such as drowsiness and dizziness, that increases the risk of falls, driving impairment, visual impairment, cognitive impairment, and upon discontinuation may cause paradoxical rebound insomnia, delirium, and nightmares all of which exacerbate the initial insomnia. All of the negative aspects of sleeping aid use are exaggerated for older, frail adults. Some patients experience an early (young-age) onset dementia with a substantial component of insomnia. Due to the many risks associated with traditional sleeping aids they are often inappropriate in adults living with cognitive impairment and/or frailty. Lemborexant comes from a new class of medications for insomnia. Lemborexant is a dual orexin receptor antagonist that blocks the binding of wake-promoting neuropeptides orexin A and orexin B to their receptors orexin 1 receptor (OX1R) and orexin 2 receptor (OX2R), which is thought to suppress wake drive. Unlike other traditional sleeping aids, lemborexant has not shown to be significantly associated with driving impairment, rebound insomnia, or dependence/withdrawal symptoms. Also, in clinical trials it only rarely causes the types of adverse events associated with benzodiazepines and other traditional sedatives and is less often associated with discontinuations due to adverse events. While lemborexant is available on the Canadian market it is unclear how this medication will be tolerated by patients living with an early onset dementia. Understanding the effectiveness and tolerability of lemborexant will be helpful in an N of 1 trial to understand the details of effect and effectiveness in individual patients.

Conditions

Insomnia; Dementia; Frontotemporal Dementia

Outcome Measures

Primary Outcomes (5)

• Total sleep time

  Total number of hours of sleep

  Daily for 8 weeks

• Sleep onset latency (SOL)

  How long it takes to fall asleep the first time the patient goes to sleep in minutes

  Daily for 8 weeks

• Wake time after sleep onset

  How long the patient is awake overnight

  Daily for 8 weeks

• Number of night awakenings

  How many times the patient wakes overnight

  Daily for 8 weeks

• Quality of sleep

  Based on sleep quality questionnaire

  Weekly for 8 weeks

Secondary Outcomes (2)

• Presence & severity of ADRs

  Daily for 8 weeks

• Drop-out due to ADR

  Daily for 8 weeks

Study Arms (1)

lemborexant

EXPERIMENTAL

The study will be an N of 1 trial over 8 weeks were treatment with lemborexant being alternated with a placebo in an "ABBABAAB" format.

Drug: Lemborexant 5 MG

Interventions

Lemborexant 5 MG DRUG

The participant will receive 8 weeks of treatment Week 1 = placebo Week 2 = lemborexant 5mg Week 3 = lemborexant 10 mg Week 4 = placebo Week 5 = lemborexant 10 mg Week 6 = placebo Week 7 = placebo Week 8 = lemborexant 10 mg

Also known as: Lemborexant 10 MG

lemborexant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Identified by clinician investigator to have early-onset dementia and a significant component of insomnia.

You may not qualify if:

• Known sleep disorders that are contraindications for orexin antagonist therapy.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia, B3H 2E1, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Dementia; Frontotemporal Dementia

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Shanna C Trenaman, BScPharm, PhD

CONTACT

19024310559; shanna.trenaman@dal.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: The subject will not be aware what the treatment is.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: The study will be an N of 1 trial over 8 weeks were treatment with lemborexant given alternated with a placebo in an "ABBABAAB" format.

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 23, 2023
• Study Start: December 11, 2023
• Primary Completion (Estimated): December 11, 2028
• Study Completion (Estimated): December 11, 2028
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)