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

Study acronym: DARIDOR-ALZ
StatusRecruiting
PhasePhase 4
Started2024-03-13
View on ClinicalTrials.gov ↗

Amendment history

2026-06-24
Study Status, Eligibility v3
Eligibility criteria+282 characters
[...] iagnosis criteria (core clinical criteria for MCI, positive biomarker for CSF Aβ42 and/or positive plasma biomarker, and neuronal injury (hippocampal and/or temporal atrophy by [...] SE from 12 to 26 Clinical Dementia Rating CDR from 0.5 to 2 PossibleUse of CNS-active drugsmedications ifis permitted provided the dose has been stable dose for at least 3 months, including: anticholinesterase drugs (rivastigmine, donepezil, galantamine) or memantine, antidepressants SSRI (e.g. ⇅ moved fluoxetine, sertraline, paroxetine…), SNRI (e.g. venlafaxine, duloxetine), neuroleptics (e.g. clozapine, olanzapine, aripiprazol [...] [...]
2026-04-22
Study Status, Eligibility v2
Primary completion date2026-05-13→2027-05-13
Completion date2027-03-13→2028-03-13
Eligibility criteria-61 characters
[...] ime functioning, and Total sleep time estimated by interview and sleep diary was below 6 hours, on at least 3 nights per week and for at least 1 month before screening, and Insomnia Severity Scale ISI© score ≥ 15 Baseline PSG (at randomization) assessed TST < 6 hours and W [...]
2024-04-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-09-01→2026-05-13
Completion date2026-07-01→2027-03-13
Start dateestimated 2023-07-01→confirmed 2024-03-13
Study sitesdetails revised at 1 of 1 site
2023-06-20
Original filing
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 Details
NCT Number NCT05924425
Lead Sponsor University Hospital, Montpellier
Collaborators: Idorsia Pharmaceuticals Ltd.
Conditions Alzheimer Disease, Insomnia Disorder, Sleep
Enrollment 62 participants
Start Date 2024-03-13
Primary Completion 2027-05-13 (estimated)
Study Completion 2028-03-13 (estimated)
Updated on ClinicalTrials.gov 2026-06-25