NCT00744978已完成2 期
A Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Crossover Trial of Varenicline Tartrate (CP-526,555) in Patients With Mild to Moderate Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6
研究概览
简要总结
- Assess the efficacy of varenicline, relative to placebo, on a performance based measure of cognition in patients with mild to moderate Alzheimer's disease
- Evaluate the effects of varenicline on clinically relevant measures including attention and executive function, behavior, and clinician rated global change.
- Evaluate the safety and tolerability of varenicline, relative to placebo, in patients with mild to moderate Alzheimer's disease
- Evaluate the pharmacokinetics of varenicline in patients with mild to moderate Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, age 55-85
- •Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- •Mini-mental status exam score of 14-26 inclusive
- •Rosen-Modified Hachinski Ischemia Score of < or = 4
排除标准
- •Diagnosis or history of other dementia or neurodegenerative disorders
- •Diagnosis or history of clinically significant cerebrovascular or cardiovascular disease
- •Subjects with pulmonary disease or evidence of clinically significant pulmonary symptoms
研究组 & 干预措施
Varenicline
Experimental
干预措施: Varenicline (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6
时间窗: Week 6
12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.
次要结局
- Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3(Week 3)
- Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6(Week 6)
- Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3(Week 3)
- Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6(Week 6)
- Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6(Week 6)
- Neuropsychiatric Inventory (NPI) Total Score at Week 3(Week 3)
- Neuropsychiatric Inventory (NPI) Total Score at Week 6(Week 6)
- Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1(Week 1)
- Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3(Week 3)
- Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6(Week 6)
- Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1(Week 1)
- Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3(Week 3)
- Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6(Week 6)
- Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1(Week 1)
- Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3(Week 3)
- Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1(Week 1)
- Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3(Week 3)
- Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6(Week 6)
- Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1(Week 1)
- Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3(Week 3)
- Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6(Week 6)
研究者
研究点 (1)
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