Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: December 2008
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Memantine
- 20mg once daily oral dose
- Drug: Placebo
- Daily oral dose
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Memantine
- Placebo Comparator: Placebo
Outcome Measures for this Clinical Trial
Primary Measures
- No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: H. Lundbeck A/S Industry
Overall Clinical Trial Officials and Contacts
Email contact via H. Lundbeck A/S Study Director LundbeckClinicalTrials@lundbeck.com
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00855686
Study ID Number: 11018
ClinicalTrials.gov Identifier: NCT00855686
Health Authority: Austria: Federal Office for Safety in Health Care
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00855686
