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

ISRCTN	ISRCTN89624516
DOI	https://doi.org/10.1186/ISRCTN89624516
Secondary identifying numbers	MEMDLBPDD2005-2 ver.3

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

Study design	Multicentre double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	MEMDPDDLB
Study objectives	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(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) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/06/2006
Completion date	28/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	74
Key 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
Key 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
Date of first enrolment	01/06/2006
Date of final enrolment	28/02/2009

Locations

Countries of recruitment

Norway
Sweden
United Kingdom

Study participating centre

Stavanger University Hospital

Stavanger
4095
Norway

Sponsor information

Stavanger Helseforskning AS (Norway)
Research organisation

Armauer Hansens vei 18
Pb 3118 Hillevåg
Stavanger
4095
Norway

"ROR"	https://ror.org/009vyay43

Funders

Funder type

Research organisation

Stavanger Helseforskning AS (Norway)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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

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