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Drug Development.

Nolan-Patrick Cunningham1,2, Jennifer Tremblay-Mercier1,2, Andrée-Ann Baril3,4

  • 1Douglas Mental Health University Institute, Montreal, QC, Canada.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 26, 2025
PubMed
Summary

This study investigates Lemborexant and CBT-I for Alzheimer's disease (AD) risk. Lemborexant may reduce AD biomarkers and improve cognition, with CBT-I enhancing these effects.

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Area of Science:

  • Neuroscience
  • Sleep Medicine
  • Pharmacology

Background:

  • Poor sleep is a modifiable risk factor for Alzheimer's Disease (AD) development and progression.
  • Sleep interventions, including Dual Orexin Receptor Antagonists (DORAs) like Lemborexant and Cognitive Behavioural Therapy for Insomnia (CBT-I), show potential in improving AD risk profiles.
  • DORAs may decrease tau phosphorylation and beta-amyloid (Aβ) levels.

Purpose of the Study:

  • To assess the impact of Lemborexant, with or without CBT-I, on AD blood biomarkers and cognitive function in individuals at risk for AD dementia.
  • To evaluate the efficacy of Lemborexant and CBT-I as potential interventions for mitigating AD risk.

Main Methods:

  • A 12-month, double-blind, randomized clinical trial involving 220 participants (aged 50-90) with insomnia symptoms.
  • Participants are randomized into four groups: Lemborexant, Lemborexant + CBT-I, placebo, or placebo + CBT-I.
  • Sleep hygiene education is provided to all participants.

Main Results:

  • Primary outcomes include changes in plasma p-tau181 and the modified Preclinical Alzheimer's Cognitive Composite score.
  • Secondary outcomes involve changes in plasma p-tau217, cerebrospinal fluid (CSF) Aβ 42/40, CSF p-tau181, and objective sleep measures via electroencephalogram (EEG).
  • Anticipated results suggest Lemborexant may reduce plasma p-tau181 and improve sleep and cognition, with CBT-I potentially augmenting these benefits.

Conclusions:

  • This research will enhance understanding of sleep interventions' therapeutic potential in AD prevention.
  • The study aims to clarify the influence of DORAs on AD biomarkers and cognitive function.
  • Findings may inform future strategies for managing AD risk through improved sleep.