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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00855686
First received: March 3, 2009
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  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 Blind (Subject, 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:

U.S. FDA Resources

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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855686

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
Study First Received: March 3, 2009
Last Updated: March 19, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by H. Lundbeck A/S:
Memantine
Cognition
Parkinson's Disease Dementia
Dementia With Lewy Bodies

Additional relevant MeSH terms:
Dementia
Delirium, Dementia, Amnestic, Cognitive Disorders
Parkinson Disease
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases
 Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013