A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease (AD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12
研究概览
简要总结
The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients, 50 years or older, native English speakers, meeting National Institute of Neurological and Communicative Disorders and Stroke--Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD with a Mini Mental State Examination (MMSE) score of 10 to 19 at Screening and Baseline
排除标准
- •Current Diagnostic and Statistical Manual of Mental Disorders--Fourth Edition (DSM-IV) Axis I disorder other than AD
- •Previous imaging results not consistent with the diagnosis of AD
- •Modified Hachinski Ischemia Score greater than 4
- •Evidence of other neurologic disorders
- •Clinically significant systemic disease
- •A known or suspected history of alcohol or drug abuse in the past 5 years
- •Taking excluded medication
- •Previous treatment with commercial memantine
研究组 & 干预措施
1
Memantine 20mg (10mg twice daily) oral administration for 12 weeks
干预措施: Memantine (Drug)
2
Placebo oral administration twice daily for 12 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12
时间窗: Baseline to Week 12
FLCI is a standardized \& validated instrument for evaluating functional communication in pts with moderate-to-severe Alzheimer's that can be used to obtain Baseline information \& to track patients' capabilities thereafter. The FLCI evaluates 10 areas: greeting and naming, answering questions, writing, sign comprehension, object-to-picture matching, word reading and comprehension, following commands, pantomime, gesture, and conversation. The FLCI total score ranges from 0 to 87, a higher score denotes better functional communication, and takes approximately 30 minutes to complete.
次要结局
- Change From Baseline in American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) [Total Score of Social Communication and Communication of Basic Needs Subscores] at Week 12(Baseline to Week 12)