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

H. Lundbeck A/S0 个研究点目标入组 200 人开始时间: 2006年10月9日最近更新: 2019年11月25日

试验速览

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•Main Inclusion Criteria
•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 probable 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 equal to or less than III 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Main Exclusion Criteria
•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 serum creatinine >130 micromol/L in lab tests done at screening

发起方