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New treatment option for Alzheimer Disease
Official title Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
ClinicalTrials.gov ID: NCT05924425
What this study is testing
What is Daridorexant 50 mg?
Daridorexant 50 mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for alzheimer disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 85
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...
- Total sleep time causes clinically significant distress or impairment in daytime functioning, and
See the full eligibility 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 \ 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...
- 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...
- 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
- Patients significantly dependent on caregivers
- Institutionalized patients
- Analphabetism or people 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)...
- 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).
- people not covered by public health insurance
- Failure to obtain written informed consent after a reflection period
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
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, 60 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.