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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004109-27-SE

Enrollment

Registered

2006-01-24

Start date

2006-03-24

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Ebixa Product Name: Ebixa Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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).	—

Measure

Time frame

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. 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).

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026