Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies
Information source: H. Lundbeck A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease Dementia; Dementia With Lewy Bodies
Intervention: Memantine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: H. Lundbeck A/S Official(s) and/or principal investigator(s): Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
DE001, Munich 80804, Germany
Additional Information
Starting date: January 2007
Last updated: September 19, 2013
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