Condition category
Nervous System Diseases
Date applied
06/04/2006
Date assigned
13/04/2006
Last edited
04/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dag Aarsland

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MEMDLBPDD2005-2 ver.3

Study information

Scientific title

Acronym

MEMDPDDLB

Study hypothesis

Dementia 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

Ethics approval received from the Regional Committees for Medical Research Ethics (REK) on the 7th November 2005 (ref: 210.05).

Study design

Multicentre double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Parkinson’s disease dementia or dementia with Lewy bodies

Intervention

Memantine versus placebo

Added as of 24/09/2008: Recruitment has been completed. Seventy-five patients were randomised.

Intervention type

Drug

Phase

Not Specified

Drug names

Memantine

Primary outcome measures

Clinician's global impression of change (CGIC)

Secondary outcome measures

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

Overall trial start date

01/06/2006

Overall trial end date

28/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

74

Participant exclusion criteria

1. 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

Recruitment start date

01/06/2006

Recruitment end date

28/02/2009

Locations

Countries of recruitment

Norway, Sweden, United Kingdom

Trial participating centre

Stavanger University Hospital
Stavanger
4095
Norway

Sponsor information

Organisation

Stavanger Helseforskning AS (Norway)

Sponsor details

Armauer Hansens vei 18
Pb 3118 Hillevåg
Stavanger
4095
Norway

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Stavanger Helseforskning AS (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19520613

Publication citations

  1. Results

    Aarsland D, Ballard C, Walker Z, Bostrom F, Alves G, Kossakowski K, Leroi I, Pozo-Rodriguez F, Minthon L, Londos E, Memantine in patients with Parkinson's disease dementia or dementia with Lewy bodies: a double-blind, placebo-controlled, multicentre trial., Lancet Neurol, 2009, 8, 7, 613-618, doi: 10.1016/S1474-4422(09)70146-2.

Additional files

Editorial Notes