Alzheimer's in Long-Term Care--Treatment for Agitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean Clinical Global Impression of Change (CGIC) at Last Observation
研究概览
简要总结
The purpose of this study is to see if a medication called prazosin is useful in the treatment of agitation and aggression in persons with Alzheimer's disease (AD) and other types of dementia in late life.
详细描述
Although the occurrence of disruptive agitation behaviors likely are influenced by environmental/ interpersonal factors, it is also likely that behaviorally relevant neurobiologic abnormalities lower the threshold for the expression of such behavior in Alzheimer's disease. Because of the success prazosin has had in the treatment of Posttraumatic Stress Disorder, it is thought that it could be used similarly with disruptive agitation. Originally designed to evaluate Alzheimer's disease patients in nursing homes, the study now includes outpatients. It is a 9-week placebo-controlled trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No age limit
- •probable/possible Alzheimer's disease diagnosis
- •disruptive agitated behaviors (e.g., irritability, aggression, uncooperativeness, pacing)
- •no hypotension
- •no concurrent use of alpha-1-blockers
- •no delirium, schizophrenia, mania, psychotic symptoms.
排除标准
- •Cardiovascular: unstable angina, recent myocardial infarction, second or third degree atrioventricular (AV) block, preexisting hypotension (systolic blood pressure less than 110) or orthostatic hypotension
- •Other medical exclusions: chronic renal or hepatic failure, or any unstable medical condition
- •Exclusionary medications: current treatment with prazosin, other alpha-1-blockers
- •Current enrollment in a separate investigational drug trial
- •Psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. Partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. Although not formally rated, this improvement is equivalent to a Clinical Global Impression of Change (CGIC) rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient).
- •Psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.
研究组 & 干预措施
prazosin
干预措施: prazosin (Drug)
placebo (inert substance)
干预措施: placebo (inert substance) (Drug)
结局指标
主要结局
Mean Clinical Global Impression of Change (CGIC) at Last Observation
时间窗: Week 8
The Clinical Global Impression of Change (CGIC) is a 7 point scale, where 1 indicates "markedly improved," 4 indicates "no change," and 7 indicates "markedly worse."
Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation
时间窗: Weeks 2, 4, 6, and 8 (change from Baseline)
The Neuropsychiatric Inventory (NPI) is a 12-item scale that assesses the frequency and severity of behavioral symptoms in patients with dementia. Each Neuropsychiatric Inventory item ranges from 0 to 12. Therefore the Neuropsychiatric Inventory total score has a minimum total value of 0 and maximum 144, where 144 indicates higher levels of behavioral symptoms. A change in Neuropsychiatric Inventory total score that is a negative number (that is, an Neuropsychiatric Inventory score decrease), indicates behavioral improvement.
次要结局
- Number of Behavioral Assessment Visits Completed(Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8))
- Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation(Weeks 2, 4, 6, and 8 (change from Baseline))