Status:
COMPLETED
Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Parkinson's Disease Dementia
Dementia With Lewy Bodies
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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
- Evidence of clinically significant active disease, evidence of other neurological disorders, and current treatment with AChEIs.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00855686
Start Date
January 1 2007
End Date
January 1 2009
Last Update
September 20 2013
Active Locations (1)
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1
DE001
Munich, Germany, 80804