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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

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 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




Primary Outcome Measures :
  1. 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
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.

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
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

Publications of Results:
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00855686     History of Changes
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:
Lewy Body Disease
Parkinson Disease
Dementia
Alzheimer 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