NCT05924425 Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
| NCT ID | NCT05924425 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Montpellier |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2024-03-13 |
| Primary Completion | 2027-05-13 |
Trial Parameters
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Brief Summary
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.
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 distress or impairment in daytime functioning, and * Total sleep time estimated by interview was below 6 hours, on at least 3 nights per week and for at least 1 month before screening * Baseline PSG (at randomization) assessed TST \< 6 hours and WASO \> 1 hour * Diagnosis of MCI and AD patients at an early stage according to the NIA diagnosis criteria (core clinical criteria for MCI, positive biomarker for CSF Aβ42 and neuronal injury (hippocampal and/or temporal atrophy by MRI)) * MMSE from 12 to 26 * Clinical Dementia Rating CDR from 0.5 to 2 * Possible of CNS drugs if stable dose for at least 3 months: anticholinesterase drugs (rivastigmine, donepezil, galantamine) or memantine * For a male subject
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