A double-blind, placebo-controlled multi-centre trial of memantine in patients with Parkinsons’ disease dementia or dementia with Lewy bodies - MEMDLBPDD

Conditions: Parkinsons disease (PD)and dementia with Lewy bodies (DLB) are both common disease of the elderly. The majority of patients who survive for more than 10 years with PD eventually develope dementia (PDD). The brain changes and clinical presentations of PDD and DLB are similar. The clinical characteristics are cognitive impairment with pronounced visuospatial and executive impairment, visual hallucinations, parkinsonism, fluctuations in cognition and REM sleep disorder.

Registration Number: EUCTR2005-004109-27-SE

Lead Sponsor: europsychiatric clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

The patients should meet all of the following criteria:
a diagnosis of PD and PD-dementia or DLB.
mild-to-moderate disease
the subject has given an informed consent
the subject is able and willing to comply with the study procedures and has a reliable carer
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

Other brain disease
mental retardation
terminal illness
recent changes in health status
major depression
epilepsy
severe dementia
moderate to severe renal, heart, hepatic or lung disease
women of childbearing potential/lactating
allergy to the IMP

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the efficacy on cognition and motor function and safety of memantine in patients with PDD and DLB compared to age and sex matched DLB and PDD patients treted with placebo.;Secondary Objective: ;Primary end point(s): Primary outcome: result in a global measurement, CGIC Global impression of change.<br>Secondary outcomes: results in cognitive tests (mini mental test, A quick test, Cognitive Drug Research Test), Neuropsychiatric Inventory, Disability assessment for dementia (ADL), QoLAD (quality of life) and motor function (UPDRS).

Secondary Outcome Measures