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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00630500
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : July 28, 2015
King's College London
Lund University
Information provided by (Responsible Party):
Helse Stavanger HF

Brief Summary:
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 or disease Intervention/treatment Phase
Dementia Associated With Parkinson's Disease Dementia With Lewy Bodies Drug: Memantine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : February 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Clinical Global Impression of Change [ Time Frame: Month 3 and 6 after baseline ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00630500

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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
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Principal Investigator: Dag Aarsland, MD, PhD Helse Stavanger HF

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Responsible Party: Helse Stavanger HF Identifier: NCT00630500    
Other Study ID Numbers: MEMPDD-130206
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: February 2009
Keywords provided by Helse Stavanger HF:
Dementia associated with Parkinson's disease
Dementia with Lewy bodies
Parallel group
Additional relevant MeSH terms:
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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