A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 150
- 主要终点
- CMAI
研究概览
简要总结
To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory [CMAI] total score from baseline as the primary efficacy variable), dose-response, and safety of aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation associated with Alzheimer's type dementia
详细描述
This trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, comparison trial to assess the efficacy and safety of aripiprazole in patients with agitation associated with Alzheimer's type dementia. Screening period is 4 weeks. Patients are randomly assigned to one of 4 groups, and treatment period is 10 weeks. Period of post-treatment observation is 30 days.
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
- 年龄范围
- 55 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible).
- •Patients who satisfy both of the following diagnostic criteria:
- •Diagnosis of major neurocognitive disorder due to Alzheimer's disease according to Diagnostic and Statistical Manual of mental disorders (DSM-5)
- •Diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- •Hospitalized patients or care facility patients
- •Patients with an Mini-Mental State Examination (MMSE) score of 1 to 22
排除标准
- •Patients with complications of dementia or memory impairment other than Alzheimer's type dementia
- •Dementia patients with a Modified Hachinski Ischemic Score of 5 or higher
- •Patients with psychological symptoms or behavioral disorders that are clearly due to other medical conditions or substances
- •Patients with a complication or history of stroke or transient ischemic attack, except for asymptomatic stroke
- •Patients with heart failure classified as New York Heart Asscoiation (NYHA） III or IV
- •Patients who require drug therapy for arrhythmia or ischemic heart disease
- •Body weight of less than 30 kg
- •Patients with a high risk of suicide
- •Patients with a complication or history of seizure disorder
- •Patients with a complication or history of neuroleptic malignant syndrome, tardive dyskinesia, paralytic ileus, or rhabdomyolysis
- •Patients with thyroid disease (except if the disease has been stabilized with drug therapy for 3 months or longer prior to time of informed consent)
研究组 & 干预措施
Aripiprazole, 2 mg/day
干预措施: 2 mg/day (Drug)
Aripiprazole, 3 mg/day
干预措施: 3 mg/day (Drug)
Aripiprazole, 6 mg/day
干预措施: 6 mg/day (Drug)
Placebo
干预措施: Placebo (0 mg/day) (Drug)
结局指标
主要结局
CMAI
时间窗: Baseline, 10 weeks
Change from baseline
次要结局
- Clinical Global Impression-Improvement (CGI-I)(10 Weeks)
- Clinical Global Impression of Severity （CGI-S）(Baseline, 10 weeks)