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Daridorexant to treat insomnia in patients with mild cognitive impairment and mild to moderate Alzheimer disease.
EU CTIS ID: 2023-503301-10-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Patients significantly dependent on caregivers
- 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)
See the full eligibility criteria
Who can join
- 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)
What rules you out
- Patients significantly dependent on caregivers
- 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
- Institutionalized patients
- Failure to obtain written informed consent after a reflection period
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.