Using daridorexant to improve sleep in patients with mild cognitive impairment and Alzheimer's disease
Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
This study is testing if daridorexant can help improve sleep for people with mild cognitive impairment and Alzheimer's disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05924425 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist, in treating insomnia among patients with mild cognitive impairment (MCI) and mild to moderate Alzheimer's disease (AD). The study is designed as a monocentric, randomized, double-blind, placebo-controlled, two-way crossover trial, where participants will receive either daridorexant or a placebo over two one-month periods, separated by a washout phase. Participants will undergo baseline polysomnography to assess their sleep patterns before treatment assignment. The trial aims to recruit 62 patients and includes a ten-month open-label phase following the initial treatment periods.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 60 to 85 with mild cognitive impairment or mild to moderate Alzheimer's disease who experience significant insomnia.
Not a fit: Patients with severe cognitive impairment or those not meeting the specific insomnia criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and overall well-being for patients suffering from insomnia related to cognitive decline.
How similar studies have performed: Other studies have shown promise with similar approaches using orexin receptor antagonists, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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 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 depression or suicidal ideation/attempt or other psychiatric conditions * 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 * Psychotropic drugs: antidepressants (SSRI (e.g. fluoxetine, sertraline, paroxetine…), SNRI (e.g. venlafaxine, duloxetine)), neuroleptics (e.g. clozapine, olanzapine, aripiprazole...), and hypnotics (benzodiazepines, zolpidem, zopiclone) or drug for pain (level 2 (e.g. codeine, tramadol), and 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
Where this trial is running
Montpellier
- University Hospital, Montpellier — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Yves Dauvilliers, MD — University Hospital, Montpellier
- Study coordinator: Yves Dauvilliers, MD
- Email: y-dauvilliers@chu-montpellier.fr
- Phone: +33467336361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.