NCT01142258已完成3 期
Trazodone for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomised, Double-blind, Placebo-controlled Study
Brasilia University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年3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
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline in Nighttime Total Sleep Time
研究概览
简要总结
The purpose of this study is to determine whether trazodone is effective 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. Trazodone is commonly prescribed drugs for SD in AD patients. There are no controlled studies in this sample of patients for this purpose.
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
- •Fifty-five years of age or older;
- •Diagnosis of probable Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke/the Alzheimer's Disease and Related Disorders Association criteria;
- •Hachinski Ischemia Scale score less than 5
- •Mini-Mental State Examination score of O 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;
- •For-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 infarct 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 principal 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 medications within 2 weeks of the screening visit;
- •Patient unwilling to maintain caffeine abstinence after 2:00 PM 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 6:00 PM for the duration of the protocol;
- •Prior use of trazodone for the treatment of sleep disturbances;
- •Caregiver deemed too unreliable to supervise the wearing of the actigraph, to administer trazodone the proper time, to maintain tbe sleep diary, or to bring the patient to the scheduled visits;
研究组 & 干预措施
Placebo
Placebo Comparator
Inert pill
干预措施: Placebo (Drug)
Trazodone
Experimental
Study group will receive trazodone 50mg
干预措施: Trazodone (Drug)
结局指标
主要结局
Change from Baseline in Nighttime Total Sleep Time
时间窗: Baseline, 14 days follow-up
次要结局
- Change from Baseline in Nighttime Wake After Sleep Onset(Baseline, 14 days follow-up)
- Change from Baseline in Nighttime Number Of Awakenings(Baseline, 14 days follow-up)
- Change from Baseline in Daytime Total Sleep Time(Baseline, 14 days follow-up)
- Change from Baseline in Number of Daytime Naps(Baseline, 14 days follow-up)
- change in cognitive function (as measured by the Mini-Mental State Examination)(Baseline, 14 days follow-up)
- Change in activities of daily living (The index of ADL - Katz)(Baseline, 14 days follow-up)
- Change of baseline in behavioral variables (BAHAVE-AD scale)(Baseline, 14 days follow-up)
- Proportion of subjects who gained at least 30 minutes in total nighttime sleep(Baseline, 14 days follow-up)
- Change from Baseline in Clinical Dementia Rating(Baseline, 14 days follow-up)
- Change from Baseline in cognitive function (Digit Symbol Substitution Test)(Baseline, 14 days follow-up)
研究者
Einstein Francisco de Camargos
MD
Brasilia University Hospital
研究点 (1)
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