Back to resultsMemantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies
Primary Purpose
Parkinson's Disease Dementia, Dementia With Lewy Bodies
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Memantine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease Dementia focused on measuring Memantine, Cognition, Parkinson's Disease Dementia, Dementia With Lewy Bodies
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.
Sites / Locations
- DE001
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Memantine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00855686
Brief Title
Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease Dementia, Dementia With Lewy Bodies
Keywords
Memantine, Cognition, Parkinson's Disease Dementia, Dementia With Lewy Bodies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Memantine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Ebixa®
Intervention Description
20mg once daily oral dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily oral dose
Primary Outcome Measure Information:
Title
No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
DE001
City
Munich
ZIP/Postal Code
80804
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20729148
Citation
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.
Results Reference
result
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Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies
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