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Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB) (MEMPDD)

This study has been completed.
Sponsor:
Collaborators:
King's College London
Lund University
Information provided by:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00630500
First received: February 27, 2008
Last updated: July 26, 2010
Last verified: February 2009
History of Changes
  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 2

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:

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 May 16, 2013