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

This study has been completed.
King's College London
Lund University
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
First received: February 27, 2008
Last updated: July 27, 2015
Last verified: February 2009
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:

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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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: NCT00630500

Stavanger University Hospital, Old Age Psychiatry Clinic
Stavanger, Norway, 4005
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
Principal Investigator: Dag Aarsland, MD, PhD Helse Stavanger HF
  More Information

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00630500     History of Changes
Other Study ID Numbers: MEMPDD-130206 
Study First Received: February 27, 2008
Last Updated: July 27, 2015
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Helse Stavanger HF:
Dementia associated with Parkinson's disease
Dementia with Lewy bodies
Parallel group

Additional relevant MeSH terms:
Lewy Body Disease
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Anti-Dyskinesia Agents
Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2016