EUCTR2005-002038-36-ES进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson?s disease dementia or dementia with Lewy Bodies
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Male or female, out-patients of at least 50 years of age
- •? Written informed consent must be obtained from the patient (or a legally acceptable representative if applicable and if different from the responsible caregiver) and the responsible caregiver
- •? The patient has a current diagnosis of Parkinson?s disease according to the clinical diagnostic criteria of the United Kingdom Parkinson?s Disease Society Brain Bank and a current diagnosis of Parkinson?s disease
- •Dementia according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (code 294.1) or the patient has a current diagnosis of DLB according to the third report of the DLB consortium
- •? Mini Mental State Examination total score between 10 and 24 (both inclusive)
- •? Modified Hoehn & Yahr score is between I to III inclusive while ?ON?
- •? Female patient must be 2 years post-menopausal or surgically sterile
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
- •? Male or female, out-patients of at least 50 years of age
- •? Written informed consent must be obtained from the patient (or a legally acceptable representative if applicable and if different from the responsible caregiver) and the responsible caregiver
- •? The patient has a current diagnosis of Parkinson?s disease according to the clinical diagnostic criteria of the United Kingdom Parkinson?s Disease Society Brain Bank and a current diagnosis of Parkinson?s disease
- •Dementia according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (code 294.1) or the patient has a current diagnosis of DLB according to the third report of the DLB consortium
- •? Mini Mental State Examination total score between 10 and 24 (both inclusive)
- •? Modified Hoehn & Yahr score is between I to III inclusive while ?ON?
- •? Female patient must be 2 years post-menopausal or surgically sterile
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •? Patients with diagnosis of any other neurodegenerative disease other than PDD or DLB
- •? Patients who have taken AChEIs within 6 weeks prior to screening. (AChEIs are not allowed during the course of the study)
- •? Clinically significant physical illness
- •? History (within the last 10 years) of alcoholism or drug abuse
- •? Patients who have taken memantine in the past 6 months
- •? Use of disallowed concomitant medication
- •? Patients with diagnosis of any other neurodegenerative disease other than PDD or DLB
- •? Patients who have taken AChEIs within 6 weeks prior to screening. (AChEIs are not allowed during the course of the study)
- •? Clinically significant physical illness
- •? History (within the last 10 years) of alcoholism or drug abuse
- •? Patients who have taken memantine in the past 6 months
- •? Use of disallowed concomitant medication
研究者
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