Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB) - Full Text View

Sponsor:	Helse Stavanger HF
Collaborators:	King's College London Lund University
Information provided by:	Helse Stavanger HF
ClinicalTrials.gov Identifier:	NCT00630500

Purpose

A 24-week placebo-controlled parallel group multicentre trial to study the safety and efficacy of memantine in patients with dementia associated with Parkinson's disease and dementia with Lewy bodies. It is hypothesized that memantine will be safe and well tolerated, and more effective than placebo.

Condition	Intervention	Phase
Dementia Associated With Parkinson's Disease Dementia With Lewy Bodies	Drug: Memantine Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-blind, Placebo-controlled Multicentre Trial 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 Parkinson disease 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 Helse Stavanger HF:

Primary Outcome Measures:

Clinical Global Impression of Change [ Time Frame: Month 3 and 6 after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MMSE [ Time Frame: Month 3 and 6 ] [ Designated as safety issue: No ]
Alzheimer's QUick Test [ Time Frame: Month 3 and 6 ] [ Designated as safety issue: No ]
Cognitive Drug Research test [ Time Frame: Month 3 and 6 ] [ Designated as safety issue: No ]
Neuropsychiatric Inventory [ Time Frame: Month 3 and 6 ] [ Designated as safety issue: No ]
Unified Parkinson's Disease Rating Scale, part III [ Time Frame: Month 3 and 6 ] [ Designated as safety issue: No ]
Epworth Sleep Scale [ Time Frame: Month 3 and 6 ] [ Designated as safety issue: No ]
Stavanger Sleep Scale [ Time Frame: Month 3 and 6 ] [ Designated as safety issue: No ]

Enrollment:	75
Study Start Date:	February 2006
Study Completion Date:	March 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Memantine Active treatment with memantine	Drug: Memantine Tablets, 5 or 10 mg, twice daily
Placebo Comparator: Placebo Placebo matching active study drug	Drug: Placebo Tablets corresponding to 5 or 10 mg, twice daily, 6 months

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

a diagnosis of Parkinson's disease (Larsen and Dupont, 1994) and dementia (DSM IV(1987; 1994), or Dementia with Lewy bodies (McKeith et al. Neurology 2005)
mild-to-moderate or moderate dementia (i.e. MMSE 12-26, inclusive)
the subject has given a written informed consent
the subject is able and willing to comply with the study procedures and has a reliable caregiver (i.e. relative or nurse/nurse assistant who sees the patient at least weekly)

Exclusion Criteria:

other brain disease of sufficient severity to cause dementia
mental retardation
terminal illness with life expectancy shorter than 6 months
recent major changes in health status
known epilepsy or previous convulsive seizure
major depression
severe dementia as defined by a Mini-mental State Examination score of 12 or lower
moderate to severe renal impairment (i.e. serum creatinine > 1,5 upper limit normal (ULN) or creatinin clearance < 40ml/minute/1,73 m2
moderate or severe heart disease (NYHA III-IV)
moderate or severe pulmonal disease
moderate to severe hepatic impairment (bilirubin or transaminases > 2 times ULN
women of childbearing potential (i.e. not post-menopausal and not taking contraceptive
the subjects is lactating
any laboratory value(s) exceeding the limits of normality if deemed to be clinically relevant by the study physician
known allergies to the investigational product

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630500

Locations

Norway
Stavanger University Hospital, Old Age Psychiatry Clinic
Stavanger, Norway, 4005
Sweden
Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo
Malmo, Sweden, 20502
United Kingdom
Mental Health Unit
Epping, Essex, United Kingdom, CM16 6TN
King's COllege London
London, United Kingdom, SE1 1UL

Sponsors and Collaborators

Helse Stavanger HF

King's College London

Lund University

Investigators

Principal Investigator:

Dag Aarsland, MD, PhD

Helse Stavanger HF

More Information

No publications provided

Responsible Party:	Dag Aarsland, Stavanger University Hospital
ClinicalTrials.gov Identifier:	NCT00630500 History of Changes
Other Study ID Numbers:	MEMPDD-130206
Study First Received:	February 27, 2008
Last Updated:	July 26, 2010
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Helse Stavanger HF:

Dementia associated with Parkinson's disease
Dementia with Lewy bodies
Memantine
Placebo-controlled
Parallel group

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 February 09, 2012