Using daridorexant to improve sleep in patients with mild cognitive impairment and Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.