Recruiting

Lemborexant

Sponsor:

Nova Scotia Health Authority

Code:

NCT06093126

Conditions

Insomnia

Dementia

Frontotemporal Dementia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Lemborexant 5 MG

Study Details

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

Study ID

NCT06093126

Start date

Dec 11, 2023

Status verified date

Feb, 2025

Completion date

Dec 11, 2028

Anticipated

Primary completion date

Dec 11, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

1 participant

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: lemborexant

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.

Interventions

Lemborexant 5 MG

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

Primary outcome measure

  • Total sleep time [ Time Frame: Daily for 8 weeks ]
  • Sleep onset latency (SOL) [ Time Frame: Daily for 8 weeks ]
  • Wake time after sleep onset [ Time Frame: Daily for 8 weeks ]
  • Number of night awakenings [ Time Frame: Daily for 8 weeks ]
  • Quality of sleep [ Time Frame: Weekly for 8 weeks ]

Central Contacts and Locations

Central contacts

Shanna C Trenaman, BScPharm, PhD

19024310559shanna.trenaman@dal.ca

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B3H 2E1

Contacts

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Feb 21, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2025-02-21.