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Clinical Trials in France / NCT05924425
Recruiting Phase 4

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

NCT05924425 · tracked via the Priya Life Science France tracker
Phase
Phase 4
Started
2024-03-13
Last updated
2026-06-25

Condition(s) studied

Alzheimer DiseaseInsomnia DisorderSleep

Investigational drug(s) / intervention(s)

Daridorexant 50 mg →PlaceboPolysomnographyNeuropsychological assessmentQuestionnaires on sleep and behavioural problemsActimetrics24-hour Ambulatory Blood Pressure Monitoring (ABPMBiomarker assay

Daridorexant 50 mg: Patients randomized in the experimental group will receive the treatment every evening within 30 minutes of going to bed during one month. The treatment period (Period A or Period B) will be followed by a one-week (range 5-12 days) washout period at home.

Placebo: Patients randomized in the control group will receive the placebo every evening within 30 minutes of going to bed during one month. The treatment period (Period A or Period B) will be followed by a one-week (range 5-12 days) washout period at home.

Polysomnography: A full-night polysomnography recording with blood pressure and heart rate monitoring will be performed at night in the Sleep Laboratory from 11 p.m. to 7 a.m. at baseline (before the randomization) and at the end of each period (Period A/M1, Period B/M2). The recording procedure consists of an electroencephalogram, two electrooculograms, an electromyogram, an electrocardiogram, and a videographic recording. This examination is painless (the sensors are glued to the skin for the duration of the recording). The advantages of this video-polysomnography are based on the evaluation of sleep architecture, micro-arousals, respiratory events and nocturnal motor behavior.

Neuropsychological assessment: A full neuropsychological assessment will be performed at inclusion, M1, M2

Questionnaires on sleep and behavioural problems: Questionnaires on sleep and behavioural problems will be performed at inclusion, M1, M2

Actimetrics: Measurement of actimetrics for seven days in average (with a minimum of three nights required) prior to the inclusion visit, M1 visit and M2 visit.

24-hour Ambulatory Blood Pressure Monitoring (ABPM: Evaluation of the 24-hour hemodynamic profile of a patient by multiple and regular blood pressure and heart rate measurements. The ABP will be monitored at inclusion, M1 and M2

Biomarker assay: Determination of AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) in serum and cerebrospinal fluid (CSF) and dosage of Orexin-A/hypocretin-1 in the CSF

Study 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

Sex
ALL
Min age
60 Years
Max age
85 Years
Healthy volunteers
No
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 CSF Aβ42 and/or positive plasma biomarker, and neuronal injury (hippocampal and/or temporal atrophy by MRI)) * MMSE from 12 to 26 * Clinical Dementia Rating CDR from 0.5 to 2 * Use of CNS-active medications is permitted provided the dose has been stable for at least 3 months, including: anticholinesterase drugs (rivastigmine, donepezil, galantamine) or memantine, antidepressants SSRI (e.g. fluoxetine, sertraline, paroxetine…), SNRI (e.g. venlafaxine, duloxetine), neuroleptics (e.g. clozapine, olanzapine, aripiprazole...) or drug for pain level 2 (codeine, tramadol). * For a male subject who is not sterilized and is sexually active with a female partner of childbearing potential, no contraceptive methods are needed Non inclusion criteria : * Patients significantly dependent on caregivers * Institutionalized patients * Analphabetism or subjects unable to read or/and write * Patients unable to perform the neuropsychological tests * Patients unable to complete the study instruments (sleep diary) * Planned longer stay outside the region that prevents compliance with the visit schedule * Patients who cannot be followed up for at least 2 months * History of narcolepsy and/or cataplexy * History of drug or alcohol abuse or addiction * History of diagnosed and characterized psychiatric disorders (DSM-5), cured or stabilized (with or without the same treatment for at least 3 months) and excluding any current characterized psychiatric disorder (DSM-5), the diagnosis of which is established by a psychiatrist trained in geriatric psychiatry * Moderate and severe liver failure * PSG baseline evidence of significant/severe sleep-related breathing disorder (defined as \>30 apnea/hypopnea episodes per hour) * Treatments interfering with sleep-wake patterns * Use of hypnotics (benzodiazepines, zolpidem, zopiclone) or drug for pain level 3 (morphine and derivatives) * Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics (SmPC) * Forbidden and restricted concomitant medications: * Concomitant CNS-depressant medicinal products * CYP3A4 inhibitors * CYP3A4 inducers * Participation in another clinical trial or administration of an investigational product * Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship). * Subjects not covered by public health insurance * Failure to obtain written informed consent after a reflection period

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital, Montpellier Montpellier France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05924425 on ClinicalTrials.gov ↗ ← All trials in France