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

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

Genetics Home Reference related topics:

familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics:

Dementia Lewy Body Disease Parkinson's Disease

Drug Information available for:

Memantine Memantine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	A Double-Blind, Placebo-Controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies

Further study details as provided by Stavanger University Hospital:

Primary Outcome Measures:

Clinical Global Impression of Change [ Time Frame: Month 3 and 6 after baseline ] [ 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 ]

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 ]

Estimated Enrollment:	74
Study Start Date:	February 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Memantine Tablets, 5 or 10 mg, twice daily
B: Placebo Comparator	Drug: Placebo Tablets, 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

Contacts


Contact: Katja Kosssanowski, Psychol	44-207-848-8195	Katja.Kossakowski@kcl.ac.uk

Contact: Zuneera Kahn, RN	55-207-848-8071	zunera.2.khan@kcl.ac.uk

Locations


Norway
	Stavanger University Hospital, Old Age Psychiatry Clinic	Recruiting
	Stavanger, Norway, 4005
	Contact: Hilde Maryanayagam, RN 47-5151-5196 hrm@sus.no
	Contact: Ingrid Braut, RN 47-5151-5196 bril@sus.no
	Principal Investigator: Dag Aarsland, MD, PhD
	Sub-Investigator: Guido Alves, MD

Norway, Rogaland
	Department of Old Age Psychiatry, Haugesund Hospital	Recruiting
	Haugesund, Rogaland, Norway, 5528
	Principal Investigator: Arvid Rongve, MD

Sweden
	Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo	Recruiting
	Malmo, Sweden, 20502
	Contact: Marie Persson, RN 46-4033-5522 Marie.e.persson@skane.se
	Contact: Eva Falk-Langebro, RN 46-4033-5529 Eva.Falk-Langebro@skane.se
	Principal Investigator: Elisabet Londos, MD, PhD
	Sub-Investigator: Fredrik Bostrom, MD

United Kingdom
	King's COllege London	Recruiting
	London, United Kingdom, SE1 1UL
	Contact: Katja Kossanowski, RN 44-207-848-8195 Katja.Kossakowski@kcl.ac.uk
	Contact: Zuneera Kahn 44-207-848-8071 zunera.2.khan@kcl.ac.uk
	Principal Investigator: Clive Ballard, MD

United Kingdom, Essex
	Mental Health Unit	Recruiting
	Epping, Essex, United Kingdom, CM16 6TN
	Contact: Lean Lee, RN 44-12-7982-7894 lean.lee@nepft.nhs.uk
	Principal Investigator: Zuzana Walker, MD

Sponsors and Collaborators

Stavanger University Hospital

King's College London

Lund University Hospital

Investigators


Principal Investigator:	Dag Aarsland, MD, PhD	Stavanger University Hospital

More Information

Responsible Party:	Stavanger University Hospital ( Dag Aarsland )
Study ID Numbers:	MEMPDD-130206
First Received:	February 27, 2008
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00630500
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Stavanger University Hospital:

Dementia associated with Parkinson's disease

Dementia with Lewy bodies

Memantine

Placebo-controlled

Parallel group

Study placed in the following topic categories:

Excitatory Amino Acids

Ganglion Cysts

Basal Ganglia Diseases

Central Nervous System Diseases

Lewy body dementia

Lewy Body Disease

Brain Diseases

Neurodegenerative Diseases

Cognition Disorders

Dopamine

Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders

Parkinson Disease

Movement Disorders

Memantine

Parkinsonian Disorders

Dementia

Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Antiparkinson Agents

Excitatory Amino Acid Agents

Dopamine Agents

Central Nervous System Agents

Pharmacologic Actions

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on October 31, 2008

Sponsors and Collaborators:	Stavanger University Hospital King's College London Lund University Hospital
Information provided by:	Stavanger University Hospital
ClinicalTrials.gov Identifier:	NCT00630500