A double-blind, placebo-controlled multicentre trial of memantine in patients with Parkinson’s disease dementia or dementia with Lewy bodies

ISRCTN ISRCTN89624516
DOI https://doi.org/10.1186/ISRCTN89624516
Protocol serial number MEMDLBPDD2005-2 ver.3
Sponsor Stavanger Helseforskning AS (Norway)
Funder Stavanger Helseforskning AS (Norway)
Submission date
06/04/2006
Registration date
13/04/2006
Last edited
04/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Dag Aarsland
Scientific

Stavanger University Hospital
Psychiatric Clinic
P O Box 1163
Stavanger
4095
Norway

Study information

Primary study designInterventional
Study designMulticentre double-blind placebo-controlled study
Secondary study designRandomised controlled trial
Scientific title
Study acronymMEMDPDDLB
Study objectivesDementia with Lewy bodies (DLB) accounts for 15% - 20% of late onset dementia whilst Parkinson’s disease occurs in 1% of individuals over the age of 65; with at least 50% of these individuals developing symptoms of dementia (Parkinson’s disease dementia - PDD). In addition to memory problems, people with these conditions experience persistent hallucinations, Parkinsonian symptoms, marked problems with attention and fluctuating consciousness. Other symptoms that occur commonly include repeated falls, faints, temporary loss of consciousness, delusions and rapid eye movement (REM) sleep behaviour disorder.

Memantine is a safe and efficient treatment for cognitive and motor symptoms in patients with Parkinson's disease dementia (PDD) and patients with dementia with Lewy bodies (DLB)

Please note that, as of 30/09/2008, the anticipated end date of this trial has been amended from 29/02/2008 to 28/02/2009 (wrong date was entered on 24/09/2008).

Please note that, as of 24/09/2008, the end date of this trial has been updated from 01/06/2008 to 29/02/2008.
Ethics approval(s)Ethics approval received from the Regional Committees for Medical Research Ethics (REK) on the 7th November 2005 (ref: 210.05).
Health condition(s) or problem(s) studiedParkinson’s disease dementia or dementia with Lewy bodies
InterventionMemantine versus placebo

Added as of 24/09/2008: Recruitment has been completed. Seventy-five patients were randomised.
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Memantine
Primary outcome measure(s)

Clinician's global impression of change (CGIC)

Key secondary outcome measure(s)

1. Mini-mental state examination
2. Alzheimer’s quick test
3. Cognitive drug research test
4. Neuropsychiatric inventory
5. Unified Parkinson’s disease rating scale
6. Epworth sleepiness scale and Stavanger scale
7. Activities of daily living
8. Disability assessment for dementia
9. Quality of life assessment
10. Mayo fluctuation scale

Completion date28/02/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration74
Key inclusion criteria1. A diagnosis of PD (Larsen, Dupont et al. 1994) and PD-dementia (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition [DSM IV] (1987, 1994) or DLB (McKeith et al. Neurol 2005)
2. Mild-to-moderate or moderate dementia (i.e. mini mental state examination MMSE 12-26, inclusive)
3. The subject has given a written informed consent
4. 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
Key exclusion criteria1. Other brain disease of sufficient severity to cause dementia
2. Mental retardation
3. Terminal illness with life expectancy shorter than six months
4. Recent major changes in health status
5. Known epilepsy or previous convulsive seizure
6. Major depression
7. Severe dementia as defined by MMSE score of 12 or lower
8. Moderate to severe renal impairment (i.e. serum creatinine >1.5 upper limit normal (ULN) or creatinine clearance <40 ml per minute/1.73 m^2)
9. Moderate or severe heart disease (New York Heath Association [NYHA] III-IV)
10. Moderate to severe pulmonary disease
11. Moderate to severe hepatic impairment (bilirubin or transaminases >2 times ULN)
12. Women of childbearing potential (i.e. not post-menopausal and not taking contraceptive)
13. The subjects is lactating
14. Any laboratory value(s) exceeding the limits of normality if deemed to be clinically relevant by the study physician
15. Known allergies to the investigational product
Date of first enrolment01/06/2006
Date of final enrolment28/02/2009

Locations

Countries of recruitment

  • United Kingdom
  • Norway
  • Sweden

Study participating centre

Stavanger University Hospital
Stavanger
4095
Norway

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2009 Yes No
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