NCT00630500

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2006

Typical duration for phase_2

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 28, 2015

Status Verified

February 1, 2009

Enrollment Period

3 years

First QC Date

February 27, 2008

Last Update Submit

July 27, 2015

Conditions

Dementia Associated With Parkinson's DiseaseDementia With Lewy Bodies

Keywords

Dementia associated with Parkinson's diseaseDementia with Lewy bodiesMemantinePlacebo-controlledParallel group

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression of Change

    Month 3 and 6 after baseline

Secondary Outcomes (7)

  • MMSE

    Month 3 and 6

  • Alzheimer's QUick Test

    Month 3 and 6

  • Cognitive Drug Research test

    Month 3 and 6

  • Neuropsychiatric Inventory

    Month 3 and 6

  • Unified Parkinson's Disease Rating Scale, part III

    Month 3 and 6

  • +2 more secondary outcomes

Study Arms (2)

Memantine

ACTIVE COMPARATOR

Active treatment with memantine

Drug: Memantine

Placebo

PLACEBO COMPARATOR

Placebo matching active study drug

Drug: Placebo

Interventions

MemantineDRUG

Tablets, 5 or 10 mg, twice daily

Memantine
PlaceboDRUG

Tablets corresponding to 5 or 10 mg, twice daily, 6 months

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stavanger University Hospital, Old Age Psychiatry Clinic

Stavanger, 4005, Norway

Location

Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo

Malmo, 20502, Sweden

Location

Mental Health Unit

Epping, Essex, CM16 6TN, United Kingdom

Location

King's COllege London

London, London, SE1 1UL, United Kingdom

Location

MeSH Terms

Conditions

Lewy Body Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Dag Aarsland, MD, PhD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 7, 2008

Study Start

February 1, 2006

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

July 28, 2015

Record last verified: 2009-02

Locations

GB(2)NO(1)SE(1)