Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease

Recruiting Phase 4 Interventional Study
Alzheimer Disease Insomnia Disorder Sleep
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
60 – 85
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
62 (estimated)
Sponsor
University Hospital, Montpellier · Other
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About This Trial

DARIDOR-ALZ is a phase IV clinical trial designed to evaluate both the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist that blocks the actions of the orexin neuropeptides at both orexin-1 and orexin-2 receptors, in selected populations of MCI and mild-to-moderate AD patients with insomnia complaints.

Trial Locations
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Eligibility Criteria
Inclusion criteria : * Age \[60-85\] years old * Outpatients * Pre-screening: * Complaints of dissatisfaction with sleep quantity or quality, despite adequate opportunity for sleep, at least 3 nights per week and for at least 3 months, and * Total sleep time causes clinically significant distr…
Contacts

Yves Dauvilliers, MD

+33467336361

y-dauvilliers@chu-montpellier.fr

CONTACT