NCT03075241已完成3 期
Z-Drugs for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Triple-blind, Placebo-controlled Study
Brasilia University Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Nighttime Total Sleep Time
研究概览
简要总结
The purpose of this study is to determine whether Zolpidem and Zoplicone are efective in the treatment of sleep disorders in Alzheimer's disease (AD)
详细描述
Sleep disorders (SD) affects 35 to 50 percent of patients with AD. These disorders often make caring for patients at home very difficult. Zolpidem and Zoplicone are prescribed drugs for sleep disorder in AD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55 years of age or older
- •Diagnosis of probable Alzheimer's disease (AD) by National Institute of Neurological and Communicative Disorders and Stroke / the Alzheimer's Disease and Related Disorders Association Criteria
- •Hachinski Ischemia Scale less than 5
- •Mini-Mental State Examination score of 0 to 26
- •Actigraph evidence of a mean time immobile of less than 7 hours per night based on at least 7 nights of complete actigraph data collected over a single week
- •Four-week history of sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver using the Neuropsychiatric Inventory (NPI) Nighttime Behavior scale
- •Sleep disturbance observed was not present before the diagnosis of AD
- •Other co-morbidities, especially delirium, depression, chronic pain and medication use may be present, but do not cooperate in the primary symptoms
- •Computed tomography or magnetic resonance imaging since the onset of memory problems showing no more than 1 lacunar infract in a nonstrategic area and no clinical events suggestive of stroke or other intracranial disease or normal
- •Stable medications for 4 weeks prior to the screening visit
- •Having a mobile upper extremity to which to attach an actigraph
- •Residing with a responsible spouse, family member, or professional caregiver who is present during the night and would agree to assume the role of the principle caregiver for the 3-week protocol
- •Ability to ingest oral medication and participate in all scheduled evaluations
排除标准
- •Sleep disturbance associated with an acute illness, delirium or psychiatric disease
- •Clinically significant movement disorder, such as akinesia, that would affect actigraphic differentiation of sleep and wakefulness
- •Severe agitation
- •Unstable medical condition
- •Discontinuation of psychotropic or sleep medication within 2 weeks of the screening visit
- •Patient unwilling to maintain caffeine abstinence after 2:00pm for the duration of the protocol
- •Patient unwilling to comply with the maximum limit of 2 alcoholic drinks per day, and only 1 alcoholic drink after 6:00pm for the duration of the protocolo
- •Prior use of zolpidem/zoplicone for the treatment os sleep disturbances
- •Caregiver deemed to be unreliable to supervise the wearing of the actigraph, to administer study capsules at the proper time, to maintain the sleep diary, or to bring the patient to the scheduled visits
研究组 & 干预措施
Zolpidem
Experimental
Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights
干预措施: Zolpidem (Drug)
Zoplicone
Experimental
Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights
干预措施: Zoplicone (Drug)
Placebo
Placebo Comparator
Study group will receive inactive or inert capsules, which will be used as a comparator, 10pm (before bedtime) for 14 nights
干预措施: Placebo (Drug)
结局指标
主要结局
Nighttime Total Sleep Time
时间窗: Baseline, 14 days follow-up
Mean Total Sleep Time (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment
次要结局
- Ratio of daytime to nighttime sleep(Baseline, 14 days follow-up)
- Proportion of sleep time at nighttime(Baseline, 14 days follow-up)
- Nighttime Wake after Sleep Onset(Baseline, 14 days follow-up)
- Daytime Total Sleep Time(Baseline, 14 days follow-up)
- Nighttime Number of Awakenings(Baseline, 14 days follow-up)
- Proportion of patients with gain of at least 30 minutes in Total Sleep Time(Baseline, 14 days follow-up)
- Differences between sleep efficiency between the two treatments.(Baseline, 14 days follow-up)
研究者
Einstein Francisco de Camargos
Principal Investigator
Brasilia University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Insomnia and Daytime Function in OsteoarthritisSleep DisordersNCT00530556Sanofi170
招募中
2 期
The study of efficacy of melatonin, and zolpidem on the sleep quality, and severity of pain in the patients with chronic non-specific low back paiow Back Pain.Dorsalgia, unspecifiedIRCT20111109008035N4Kermanshah University of Medical Sciences48
已完成
2 期
Differential Effects of Zolpidem Versus Ramelteon in Burned ChildrenSleepBurnsNCT00539110Shriners Hospitals for Children10
已完成
4 期
Eszopiclone in the Treatment of Insomnia and FibromyalgiaInsomniaFibromyalgiaNCT00392041Lesley A. Allen, Ph.D.36
已完成
4 期
Long Term Treatment With Zolpidem: Nightly and Intermittent DosingPrimary InsomniaPsychophysiologic InsomniaInsomniaNCT00156533University of Rochester20