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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

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 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 5 years) of alcoholism or drug abuse
Patients who have taken memantine in the past 6 months
Use of disallowed concomitant medication

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to explore the efficacy and safety of memantine compared to placebo in out-patients with a diagnosis of PDD or DLB over a 6-month period;Secondary Objective: N.A.;Primary end point(s): Cognition – Verbal fluency test, Brief Extended Verbal Paired Associates test, Trails Making Test, Simple and choice reaction time, Cogstate Set shifting test, Adas-cog Orientation test, Digit ordering test, Verbal Recall and Recognition Test, Boston Naming test, Benton facial Recognition test, Benton Judgement of Line Orientation test, Ten-point clock drawing test, the Stroop interference testBehaviour – NPIGlobal – ADCS-CGICFunction – ADCS-ADLMotor function – UPDRS Caregiver burden – Zarit Burden interview

Secondary Outcome Measures

Name	Time	Method

Related Trials