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

Primary Purpose

Dementia Associated With Parkinson's Disease, Dementia With Lewy Bodies

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Memantine
Placebo
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia Associated With Parkinson's Disease focused on measuring Dementia associated with Parkinson's disease, Dementia with Lewy bodies, Memantine, Placebo-controlled, Parallel group

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stavanger University Hospital, Old Age Psychiatry Clinic
  • Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo
  • Mental Health Unit
  • King's COllege London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Memantine

Placebo

Arm Description

Active treatment with memantine

Placebo matching active study drug

Outcomes

Primary Outcome Measures

Clinical Global Impression of Change

Secondary Outcome Measures

MMSE
Alzheimer's QUick Test
Cognitive Drug Research test
Neuropsychiatric Inventory
Unified Parkinson's Disease Rating Scale, part III
Epworth Sleep Scale
Stavanger Sleep Scale

Full Information

First Posted
February 27, 2008
Last Updated
July 27, 2015
Sponsor
Helse Stavanger HF
Collaborators
King's College London, Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT00630500
Brief Title
Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB)
Acronym
MEMPDD
Official Title
A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
King's College London, Lund University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Associated With Parkinson's Disease, Dementia With Lewy Bodies
Keywords
Dementia associated with Parkinson's disease, Dementia with Lewy bodies, Memantine, Placebo-controlled, Parallel group

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine
Arm Type
Active Comparator
Arm Description
Active treatment with memantine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching active study drug
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
Tablets, 5 or 10 mg, twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets corresponding to 5 or 10 mg, twice daily, 6 months
Primary Outcome Measure Information:
Title
Clinical Global Impression of Change
Time Frame
Month 3 and 6 after baseline
Secondary Outcome Measure Information:
Title
MMSE
Time Frame
Month 3 and 6
Title
Alzheimer's QUick Test
Time Frame
Month 3 and 6
Title
Cognitive Drug Research test
Time Frame
Month 3 and 6
Title
Neuropsychiatric Inventory
Time Frame
Month 3 and 6
Title
Unified Parkinson's Disease Rating Scale, part III
Time Frame
Month 3 and 6
Title
Epworth Sleep Scale
Time Frame
Month 3 and 6
Title
Stavanger Sleep Scale
Time Frame
Month 3 and 6

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dag Aarsland, MD, PhD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stavanger University Hospital, Old Age Psychiatry Clinic
City
Stavanger
ZIP/Postal Code
4005
Country
Norway
Facility Name
Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo
City
Malmo
ZIP/Postal Code
20502
Country
Sweden
Facility Name
Mental Health Unit
City
Epping
State/Province
Essex
ZIP/Postal Code
CM16 6TN
Country
United Kingdom
Facility Name
King's COllege London
City
London
ZIP/Postal Code
SE1 1UL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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