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

July 27, 2015 updated by: Helse Stavanger HF

A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Stavanger, Norway, 4005
        • Stavanger University Hospital, Old Age Psychiatry Clinic
  • Sweden
      • Malmo, Sweden, 20502
        • Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo
  • United Kingdom
      • London, United Kingdom, SE1 1UL
        • King's College London
    • Essex
      • Epping, Essex, United Kingdom, CM16 6TN
        • Mental Health Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression of Change
Time Frame: Month 3 and 6 after baseline
Month 3 and 6 after baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

King's College London
Lund University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEMPDD-130206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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