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Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies
This study has been completed.
Sponsor:
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00855686
First received: March 3, 2009
Last updated: September 19, 2013
Last verified: September 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Parkinson's Disease Dementia Dementia With Lewy Bodies | Drug: Memantine Drug: Placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by H. Lundbeck A/S:
Primary Outcome Measures:
- No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
| Enrollment: | 199 |
| Study Start Date: | January 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Memantine |
Drug: Memantine
20mg once daily oral dose
Other Name: Ebixa®
|
| Placebo Comparator: Placebo |
Drug: Placebo
Daily oral dose
|
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| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855686
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855686
Locations
| Germany | |
| DE001 | |
| Munich, Germany, 80804 | |
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
Publications:
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT00855686 History of Changes |
| Other Study ID Numbers: |
11018 2005-002038-36 ( EudraCT Number ) |
| Study First Received: | March 3, 2009 |
| Last Updated: | September 19, 2013 |
Keywords provided by H. Lundbeck A/S:
|
Memantine Cognition Parkinson's Disease Dementia Dementia With Lewy Bodies |
Additional relevant MeSH terms:
|
Parkinson Disease Dementia Alzheimer Disease Lewy Body Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Neurocognitive Disorders |
Mental Disorders Tauopathies Memantine Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |
ClinicalTrials.gov processed this record on August 17, 2017