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

University Hospital, Montpellier1 个研究点分布在 1 个国家目标入组 62 人开始时间: 2024年3月13日最近更新: 2026年6月25日

适应症

干预措施

试验速览

阶段: 4 期
状态: 招募中
发起方: University Hospital, Montpellier
入组人数: 62
试验地点: 1
主要终点: Change in Total Sleep Time (TST).

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

This Phase IV clinical trial is a monocentric, randomized, double-blind, placebo-controlled, 2 way-crossover study (with two periods of one month separated by a washout period range from 5 to 12 days).The study population includes MCI and mild-to-moderate AD patients aged between 60 and 85 years old, with insomnia complaints.

A single-night baseline polysomnography recording will be performed from 11 pm to 7 am at the Montpellier Sleep Unit. After a baseline PSG that assessed TST < 6 hours and WASO > 1 hour, treatment will be assigned using an interactive response technology system.

A randomization list will be generated and will remain confidential until the database is locked. Participants, investigators, and site personnel will be unaware of treatment allocation during the two crossover periods. Patients will be randomized (1:1) to receive daridorexant 50 mg or placebo, without titration, every evening within 30 minutes of going to bed during both treatment periods (Treatment Period A and B) of one-month duration each. Each treatment period will be followed by a one-week (range 5-12 days) washout period at home.

A ten-month open-label (OL) study with daridorexant 50 mg will be proposed to all participants after completing the second treatment period. Based on the experience with another DORA study in patients with mild-to-moderate probable Alzheimer's disease, the investigators would need to recruit 62 patients (including drop-outs).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

入排标准

年龄范围: 60 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

未提供

研究组 & 干预措施

Placebo-controlled arm

Placebo Comparator

Patients will receive a placebo matching to daridorexant 50 mg during one month (Period A or Period B).

干预措施: Biomarker assay (Other)