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Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies

This study has been completed.
Information provided by (Responsible Party):
H. Lundbeck A/S Identifier:
First received: March 3, 2009
Last updated: September 19, 2013
Last verified: September 2013
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 Blind (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.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT00855686

Munich, Germany, 80804
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S
  More Information

Responsible Party: H. Lundbeck A/S 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:
Parkinson's Disease Dementia
Dementia With Lewy Bodies

Additional relevant MeSH terms:
Parkinson Disease
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
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 processed this record on May 25, 2017