We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00630500
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : July 28, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Primary Completion Date : February 2009
Study Completion Date : March 2009


Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00630500     History of Changes
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
Memantine
Placebo-controlled
Parallel group

Additional relevant MeSH terms:
Parkinson Disease
Dementia
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
Tauopathies
Memantine
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