Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies
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ClinicalTrials.gov Identifier: NCT00855686 |
Recruitment Status :
Completed
First Posted : March 4, 2009
Last Update Posted : September 20, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease Dementia Dementia With Lewy Bodies | Drug: Memantine Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 199 participants |
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 |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Memantine |
Drug: Memantine
20mg once daily oral dose
Other Name: Ebixa® |
Placebo Comparator: Placebo |
Drug: Placebo
Daily oral dose |
- No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855686
Germany | |
DE001 | |
Munich, Germany, 80804 |
Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Responsible Party: | H. Lundbeck A/S |
ClinicalTrials.gov Identifier: | NCT00855686 |
Other Study ID Numbers: |
11018 2005-002038-36 ( EudraCT Number ) |
First Posted: | March 4, 2009 Key Record Dates |
Last Update Posted: | September 20, 2013 |
Last Verified: | September 2013 |
Memantine Cognition Parkinson's Disease Dementia Dementia With Lewy Bodies |
Parkinson Disease Dementia Alzheimer Disease Lewy Body Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies 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 |