Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease (NCT05924425) is a Phase 4 interventional studying Alzheimer Disease and Insomnia Disorder, sponsored by University Hospital, Montpellier. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 62 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Alzheimer Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

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.

DRUG

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.

PROCEDURE

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.

BEHAVIORAL

Neuropsychological assessment

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

BEHAVIORAL

Questionnaires on sleep and behavioural problems

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

PROCEDURE

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.

PROCEDURE

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

OTHER

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University Hospital, Montpellier

Montpellier, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05924425), the sponsor (University Hospital, Montpellier), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05924425 clinical trial studying?

Who can participate in NCT05924425?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05924425?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05924425. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05924425. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.