Randomised controlled trial of memantine versus placebo in Parkinson's disease dementia

ISRCTN	ISRCTN32476322
DOI	https://doi.org/10.1186/ISRCTN32476322
Secondary identifying numbers	3

Submission date: 08/09/2005
Registration date: 14/09/2005
Last edited: 05/08/2009

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

Dr Iracema Leroi
Scientific

Park House
North Manchester General Hospital
Delaunay's Road
Crumpsall
Manchester
M8 5RB
United Kingdom

Phone	+44 (0)1617202497
Email	ILeroi2002@yahoo.co.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	To investigate the safety and efficacy of memantine used for treatment of cognitive and functional impairment in Parkinson's disease.
Ethics approval(s)	(Added 05/08/09) North Manchester Regional Ethics Committee (NMREC) gave approval on the 20th November 2003 (ref: 03/NM/359)
Health condition(s) or problem(s) studied	Parkinson's disease dementia
Intervention	Memantine, a new glutamatergic modulator used for treatment of cognitive and functional impairment in Alzheimer disease versus placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Memantine
Primary outcome measure	Neuropsychological function including measures of: 1. Global cognitive impairment with emphasis on subcortical functions as assessed by the Dementia Rating Scale (DRS)(Mattis, 1988). This scale examines five areas including: attention, initiation and perseveration, construction, conceptual ability, and memory (verbal and visual). 2. Psychomotor speed and tracking as assessed by Trail Making Test, Part A and B (TMT) (Reitan, 1958). 3. Executive function as assessed by verbal fluency (Monsch et al., 1994).
Secondary outcome measures	1. Parkinsonian motor symptoms as measured by: 1.1. The Unified Parkinsons Disease Rating Scale, motor subscore (items 18-31)(UPDRS-motor)(Fahn et al., 1987) for assessment of baseline and change in motor symptoms. This will administered during the on phase or no sooner than 30minutes after administration of anti-Parkinsonian medications. 1.2. The Hoehn-Yahr Scale (HYS)(the same as UPDRS, Part V(Hoehn and Yahr, 1967) for assessment of stage of motor severity in PD (range 0 for no signs of disease to 5 wheelchair bound or bedridden). 2. Psychiatric symptoms as measured by: 2.1. Neuropsychiatric Inventory (NPI)(Cummings et al., 1994). 2.2. Cornell Depression Rating Scale (CDRS)(Alexopolous, 1988). 2.3. Hamilton Rating Scale for Depression (Hamilton 1960). 3. Functional ability as measures by the Parkinsons Disease Questionnaire (PDQ-39) (Jenkinson et al., 1998). 4. Global measure of change as assessed by the Clinicians Interview Based Impression of Change (CIBIC+).
Overall study start date	01/01/2005
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	50
Key inclusion criteria	1. Male and female patients, minimum age of 50. 2. Have a clinical diagnosis of idiopathic Parkinsons disease (PD) according to the UK Parkinsons Disease Society Brain Bank clinical diagnostic criteria (Daniel and Lees, 1993), in the mild to moderate stage as defined by Hoehn and Yahr stage < V (Hoehn and Yahr, 1967). 3. Have a clinical diagnosis of PDD, according to DSM-IV criteria (Code 294.1), with onset of symptoms of dementia at least 1 year after the first onset of PD motor symptoms. 4. Have dementia within the range of MMSE 10-26. 5. Treatment of the motor aspects of the disease stable for at least one month prior to enrolling in the study. 6. Presence of a reliable caregiver or spouse to act as informant and monitor the study drug. 7. Stable medical history and general health. 8. Able to consent to the study, be cooperative, and able to ingest oral medication. Informed consent will be written, however, if the patient is incapable of giving written consent, their legally authorised representative must be able to provide this).
Key exclusion criteria	1. Patients known to have a sensitivity to NMDA receptor antagonists or who are currently on amantadine, ranitidine or cimetidine. 2. Presence of brain disease other than PD (such as vascular dementia, stroke) or history of neurosurgery. 3. Presence of severe medical disorders. 4. A disability that may prevent the patient from completing all study requirements (eg blindness, deafness). 5. Female patients of child-bearing potential. 6. Taken any cognitive enhancing agent, such as a cholinesterase inhibitor, during the four weeks prior to randomization.
Date of first enrolment	01/01/2005
Date of final enrolment	01/01/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Park House

Manchester
M8 5RB
United Kingdom

Sponsor information

Manchester Mental Health and Social Care Trust (UK)
Hospital/treatment centre

c/o Professor Alistair Burns
2nd Floor ERC
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
England
United Kingdom

Phone	+44 (0)1612915886
Email	alistair.burns@manchester.ac.uk

Funders

Funder type

Industry

Lundbeck Ltd £53,000 (study grant) plus £5,350 (laboratoty costs) = £58,350

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	15/06/2009		Yes	No