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

Sponsor:

Information provided by (Responsible Party):

H. Lundbeck A/S

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease Dementia Dementia With Lewy Bodies	Drug: Memantine Drug: Placebo	Phase 4

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.

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Dementia with Lewy bodies Parkinson disease

MedlinePlus related topics: Dementia Lewy Body Disease Parkinson's Disease

Drug Information available for: Memantine Memantine hydrochloride

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Memantine	Drug: Memantine 20mg once daily oral dose Other Name: Ebixa®
Placebo Comparator: Placebo	Drug: Placebo Daily oral dose

Outcome Measures

Primary Outcome Measures :

No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
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

Information from the National Library of Medicine

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

Locations

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Germany
DE001
Munich, Germany, 80804

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

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Study Director:	Email contact via H. Lundbeck A/S	LundbeckClinicalTrials@lundbeck.com

More Information

Publications of Results:

Emre M, Tsolaki M, Bonuccelli U, Destée A, Tolosa E, Kutzelnigg A, Ceballos-Baumann A, Zdravkovic S, Bladström A, Jones R; 11018 Study Investigators. Memantine for patients with Parkinson's disease dementia or dementia with Lewy bodies: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Oct;9(10):969-77. doi: 10.1016/S1474-4422(10)70194-0. Epub 2010 Aug 20.

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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

Keywords provided by H. Lundbeck A/S:


Memantine Cognition Parkinson's Disease Dementia Dementia With Lewy Bodies

Additional relevant MeSH terms:

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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

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