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Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB) (MEMPDD)
This study is currently recruiting participants.
Verified by Stavanger University Hospital, February 2009
First Received: February 27, 2008   Last Updated: February 27, 2009   History of Changes
Sponsor: Stavanger University Hospital
Collaborators: King's College London
Lund University
Information provided by: Stavanger University Hospital
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
Control: Placebo Control
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:


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 ]

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 ]

Estimated Enrollment: 74
Study Start Date: February 2006
Estimated Study Completion Date: March 2009
Primary Completion Date: February 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            
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
Investigators
Principal Investigator: Dag Aarsland, MD, PhD Stavanger University Hospital
  More Information

No publications provided

Responsible Party: Stavanger University Hospital ( Dag Aarsland )
Study ID Numbers: MEMPDD-130206
Study First Received: February 27, 2008
Last Updated: February 27, 2009
ClinicalTrials.gov Identifier: NCT00630500     History of Changes
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

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

ClinicalTrials.gov processed this record on March 18, 2010