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

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: Parkinson disease Perry syndrome

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

Drug Information available for: Memantine Memantine hydrochloride

Genetic and Rare Diseases Information Center resources: Lewy Body Dementia

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). [ Designated as safety issue: No ]


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

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. Review.


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

ClinicalTrials.gov processed this record on March 02, 2015