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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Jun 20, 2023

Keywords

ClinConnect Summary

The DARIDOR-ALZ clinical trial is studying a new medication called daridorexant, which aims to help improve sleep in patients who have mild cognitive impairment (MCI) or mild to moderate Alzheimer’s disease (AD) and are experiencing insomnia. Insomnia is a condition where people have trouble sleeping, which can affect their daily functioning and overall quality of life. This trial is looking for participants aged 60 to 85 who have been struggling with poor sleep for at least three months, sleeping less than six hours a night on average, and who meet specific criteria for MCI or AD.

If you or a loved one qualifies for this trial, you can expect to participate in regular visits where your sleep patterns will be monitored, including completing sleep diaries and undergoing assessments to evaluate your cognitive function. The trial is currently recruiting participants and aims to determine how effective and safe daridorexant is for improving sleep in this specific group of patients. It's important to note that some individuals may not be eligible, such as those with significant psychiatric conditions or those currently taking certain medications that could interfere with the study.

Gender

ALL

Eligibility criteria

• 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 and sleep diary was below 6 hours, on at least 3 nights per week and for at least 1 month before screening, and
• • Insomnia Severity Scale ISI© score ≥ 15
• • 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