Could this sleep drug help Alzheimer's patients rest better?
NCT ID NCT05924425
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether daridorexant, a sleep medication, can improve sleep in people with mild cognitive impairment or mild-to-moderate Alzheimer's disease who also have insomnia. Sixty-two participants will receive either the drug or a placebo for one month, and their sleep will be measured in a sleep lab. The goal is to see if the drug increases total sleep time and reduces nighttime awakenings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Daridorexant
- What this could lead to
- If it works, this could offer a new sleep medication option for people with Alzheimer's who also have insomnia.
- What could go wrong
- This is a small, early-phase trial with only 62 participants, so results may not apply to everyone. The drug may not improve sleep significantly or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital, Montpellier
RECRUITINGMontpellier, France
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