Daridorexant to treat insomnia in patients with mild cognitive impairment and mild to moderate Alzheimer disease.

Trial details

Who runs it

Centre Hospitalier Universitaire De Montpellier

Trial code

EU 2023-503301-10-00

Record updated

2026. június 19.

Original description

To evaluate the efficacy of oral administration of daridorexant 50 mg on the total sleep time (TST) duration as assessed via polysomnography from baseline to post-baseline, in outpatients with MCI and mild-to-moderate AD, with insomnia disorder.Read full original descriptionShow less

To evaluate the efficacy of oral administration of daridorexant 50 mg on the total sleep time (TST) duration as assessed via polysomnography from baseline to post-baseline, in outpatients with MCI and mild-to-moderate AD, with insomnia disorder.

Inclusion: 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).

Exclusion: Use of hypnotics (benzodiazepines, zolpidem, zopiclone) or drug for pain level 3 (morphine and derivatives); 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; 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); Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics (SmPC); Failure to obtain written informed consent after a reflection period; History of narcolepsy and/or cataplexy; History of drug or alcohol abuse or addiction; Patients significantly dependent on caregivers; Treatments interfering with sleep-wake patterns; 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; 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.

EU CTIS 2023-503301-10-00