2023-503301-10-00招募中4 期
Daridorexant to treat insomnia in patients with mild cognitive impairment and mild to moderate Alzheimer disease.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The change in Total Sleep Time (TST) from baseline to the end of each period (Month 1/Month 2) as assessed by polysomnography comparing daridorexant 50 mg with placebo.
研究概览
简要总结
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.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment Open Label Period (Month 2 - Month 12)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 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
排除标准
- •Patients significantly dependent on caregivers
- •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 and hypnotics)
- •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). Patients under guardianship/curatorship are accepted
- •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
结局指标
主要结局
The change in Total Sleep Time (TST) from baseline to the end of each period (Month 1/Month 2) as assessed by polysomnography comparing daridorexant 50 mg with placebo.
The change in Total Sleep Time (TST) from baseline to the end of each period (Month 1/Month 2) as assessed by polysomnography comparing daridorexant 50 mg with placebo.
次要结局
- Change in the wake time after sleep onset (WASO) from baseline to the end of each period (Month 1/Month 2) as assessed by polysomnography comparing daridorexant 50 mg with placebo.
- Changes in objective sleep parameters as assessed by polysomnography (LPS, percentage of sleep stages, wake bouts on the whole night and per quarter of the night) from baseline to the end of each period (Month 1/Month 2) comparing daridorexant 50 mg with placebo.
- Changes in sleep/wake parameters (sleep and wake duration, sleep efficiency) as assessed by actigraphy from baseline to the end of each period (Month 1/Month 2) comparing daridorexant 50 mg with placebo.
- Changes in self-reported sleep parameters (sleep questionnaires such as TST, insomnia on ISI, and excessive daytime sleepiness on ESS, IDSIQ total score, sleepiness, mood, and alert/cognition domain scores) from baseline to the end of each period (Month 1/Month 2) comparing daridorexant 50 mg with placebo.
- Change in depression (using the Beck Depression Inventory – BDI) and quality of life (using the EuroQol 5-Dimensional Descriptive System – EQ-5D) from baseline to the end of each period (Month 1/Month 2) with daridorexant 50 mg compared to placebo.
- Changes in cognition (episodic memory, executive function, verbal fluency…) and nocturnal agitation using the Neuropsychiatric Inventory (NPI) agitation/aggression domain from baseline to the end of each period (Month 1/Month 2) comparing daridorexant 50 mg with placebo.
- Decrease in blood pressure variability during polysomnography and increase in 24-hour blood pressure monitoring dipping pattern from baseline to the end of each period (Month 1/Month 2) comparing daridorexant 50 mg with placebo.
- Changes in blood AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) levels from baseline to the end of each period (Month 1/Month 2) comparing daridorexant 50 mg with placebo.
- Changes in objective sleep parameters as assessed by polysomnography according to baseline CSF AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and Orexin levels from baseline to the end of each period (Month 1/Month 2) comparing daridorexant 50 mg with placebo.
- CSF AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and CSF proinflammatory cytokines (TNFa, IL6) levels according to serum AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and serum proinflammatory cytokines (TNFa, IL6) levels at baseline.
- Rates of serious adverse events with treatment intake from baseline to the end of trial.
研究者
DAUVILLIERS YVES
Scientific
University Hospital Of Montpellier
研究点 (1)
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