Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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 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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • MMSE [ Time Frame: Month 3 and 6 ]
  • Alzheimer's QUick Test [ Time Frame: Month 3 and 6 ]
  • Cognitive Drug Research test [ Time Frame: Month 3 and 6 ]
  • Neuropsychiatric Inventory [ Time Frame: Month 3 and 6 ]
  • Unified Parkinson's Disease Rating Scale, part III [ Time Frame: Month 3 and 6 ]
  • Epworth Sleep Scale [ Time Frame: Month 3 and 6 ]
  • Stavanger Sleep Scale [ Time Frame: Month 3 and 6 ]

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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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 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 Identifier: NCT00630500     History of Changes
Other Study ID Numbers: MEMPDD-130206
Study First Received: February 27, 2008
Last Updated: July 27, 2015

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

Additional relevant MeSH terms:
Parkinson Disease
Alzheimer Disease
Lewy Body Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents processed this record on April 28, 2017