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

Phase 1

• Conditions: Patients with Parkinson’s disease dementia or dementia with Lewy Bodies; MedDRA version: 8.1 Level: LLT Classification code 10012284 Term: Dementia due to Parkinson's disease

• Registration Number: EUCTR2005-002038-36-GB
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-09
• Study Completion: 2009-01-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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 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

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified