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

Last updated: September 19, 2013
Sponsor: H. Lundbeck A/S
Overall Status: Completed

Phase

4

Condition

Dementia

Parkinson's Disease

Parkinson's With Dementia

Treatment

N/A

Clinical Study ID

NCT00855686
11018
2005-002038-36
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 199
Study Start date:
January 01, 2007
Estimated Completion Date:
January 31, 2009

Study 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.

Connect with a study center

  • DE001

    Munich, 80804
    Germany

    Site Not Available

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