Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies - Full Text View

Sponsor:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00855686

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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Perry syndrome

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

Drug Information available for: Memantine Memantine hydrochloride

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

No publications provided

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:	September 24, 2010
Health Authority:	Austria: Federal Office for Safety in Health Care France: Afssaps - French Health Products Safety Agency 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
Parkinson Disease
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
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 24, 2012