NCT00334906已完成4 期
An Open-Label Exploratory Study With Memantine: Assessment of Selected Measures of Volumetric MRI and Cognition in Patients With Moderate Dementia of the Alzheimer's Type
Forest Laboratories2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Total brain atrophy on MRI
研究概览
简要总结
The purpose of this study is to characterize the progression of disease using volumetric MRI techniques and cognitive outcome measures in patients with moderate dementia of the Alzheimer's type treated with open-label memantine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Ambulatory male or female patients at least 50 years of age (females at least 2 years postmenopausal)
- •A diagnosis of probable AD [according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA) criteria] of moderate severity [Mini-Mental State Examination score between 15 and 20, inclusive]
- •On a stable dose of Food and Drug Administration (FDA)-approved acetylcholinesterase inhibitor
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
- •Inability to participate in MRI testing
- •No clinically significant systemic disease
- •A known or suspected history of alcohol or drug abuse in the past 10 years
- •Taking excluded medication
- •Previous treatment with commercial memantine
结局指标
主要结局
Total brain atrophy on MRI
Efficacy
次要结局
- Safety
- Other measures of brain atrophy on MRI, change from baseline in selected cognitive measures assessing multiple cognitive domains including memory, attention, motor-speed, auditory comprehension, and verbal fluency
研究者
研究点 (2)
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