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A double-blind, placebo-controlled multicentre trial of memantine in patients with Parkinsonís disease dementia or dementia with Lewy bodies
DOI 10.1186/ISRCTN89624516
ClinicalTrials.gov identifier
EudraCT number
Public title A double-blind, placebo-controlled multicentre trial of memantine in patients with Parkinsonís disease dementia or dementia with Lewy bodies
Scientific title
Serial number at source MEMDLBPDD2005-2 ver.3
Study hypothesis Dementia with Lewy bodies (DLB) accounts for 15% - 20% of late onset dementia whilst Parkinsonís disease occurs in 1% of individuals over the age of 65; with at least 50% of these individuals developing symptoms of dementia (Parkinsonís 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.
Lay summary
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
Countries of recruitment Norway, Sweden, United Kingdom
Disease/condition/study domain Parkinsonís disease dementia or dementia with Lewy bodies
Participants - 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
Participants - 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
Anticipated start date 01/06/2006
Anticipated end date 28/02/2009
Status of trial Completed
Patient information material
Target number of participants 74
Interventions Memantine versus placebo

Added as of 24/09/2008: Recruitment has been completed. Seventy-five patients were randomised.
Primary outcome measure(s) Clinician's global impression of change (CGIC)
Secondary outcome measure(s) 1. Mini-mental state examination
2. Alzheimerís quick test
3. Cognitive drug research test
4. Neuropsychiatric inventory
5. Unified Parkinsonís 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
Sources of funding Stavanger Helseforskning AS (Norway)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19520613
Contact name Prof  Dag  Aarsland
  Address Stavanger University Hospital
Psychiatric Clinic
P O Box 1163
  City/town Stavanger
  Zip/Postcode 4095
  Country Norway
Sponsor Stavanger Helseforskning AS (Norway)
  Address Armauer Hansens vei 18
Pb 3118 Hillevåg
  City/town Stavanger
  Zip/Postcode 4095
  Country Norway
Date applied 06/04/2006
Last edited 04/08/2009
Date ISRCTN assigned 13/04/2006
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