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 Parkinsons disease occurs in 1% of individuals over the age of 65; with at least 50% of these individuals developing symptoms of dementia (Parkinsons 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
Parkinsons 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 measure
Clinician's global impression of change (CGIC)
Secondary outcome measures
1. Mini-mental state examination
2. Alzheimers quick test
3. Cognitive drug research test
4. Neuropsychiatric inventory
5. Unified Parkinsons 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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19520613
Publication citations
-
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.