Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies

NCT ID: NCT00855686

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-01-31

Brief Summary

The purpose of this exploratory study is to determine whether memantine can provide benefits on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy Bodies.

Detailed Description

The objective of this exploratory study is to assess the benefits of memantine compared to placebo in out-patients with a diagnosis of Parkinson's Disease Dementia or Dementia with Lewy Bodies (mild to moderate severity) over a 6-month period. This is a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study with specific cognitive (attention, executive function, visual perception and memory), behavioural, functional and global measures.

Conditions

Parkinson's Disease Dementia; Dementia With Lewy Bodies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Memantine

Group Type: EXPERIMENTAL

Memantine

Intervention Type: DRUG

20mg once daily oral dose

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Daily oral dose

Interventions

Memantine

20mg once daily oral dose

Intervention Type: DRUG

Placebo

Daily oral dose

Intervention Type: DRUG

Other Intervention Names

Ebixa®

Eligibility Criteria

Inclusion Criteria

• The study population will consist of male or female outpatients at least 50 years of age with mild to moderate disease severity (MMSE 12 to 24 inclusive) according to UKPDS and DSM IV TR criteria (for PDD patients) and the third report of the DLB consortium (for DLB patients) and who have a knowledgeable and reliable caregiver to accompany the patient to all clinic visits during the course of the study.

Exclusion Criteria

• Evidence of clinically significant active disease, evidence of other neurological disorders, and current treatment with AChEIs.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

DE001

Munich, , Germany

Countries

Germany

References

Emre M, Tsolaki M, Bonuccelli U, Destee A, Tolosa E, Kutzelnigg A, Ceballos-Baumann A, Zdravkovic S, Bladstrom A, Jones R; 11018 Study Investigators. Memantine for patients with Parkinson's disease dementia or dementia with Lewy bodies: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Oct;9(10):969-77. doi: 10.1016/S1474-4422(10)70194-0. Epub 2010 Aug 20.

Reference Type: RESULT

PMID: 20729148 (View on PubMed)

Other Identifiers

2005-002038-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11018

Identifier Type: -

Identifier Source: org_study_id