Contact information
Type
Scientific
Primary contact
Dr Iracema Leroi
ORCID ID
Contact details
Park House
North Manchester General Hospital
Delaunay's Road
Crumpsall
Manchester
M8 5RB
United Kingdom
+44 (0)1617202497
ILeroi2002@yahoo.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3
Study information
Scientific title
Acronym
Study hypothesis
To investigate the safety and efficacy of memantine used for treatment of cognitive and functional impairment in Parkinson's disease.
Ethics approval
(Added 05/08/09) North Manchester Regional Ethics Committee (NMREC) gave approval on the 20th November 2003 (ref: 03/NM/359)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Memantine
Primary outcome measures
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 trial start date
01/01/2005
Overall trial end date
01/01/2007
Reason abandoned
Eligibility
Participant 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).
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
50
Participant 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.
Recruitment start date
01/01/2005
Recruitment end date
01/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Park House
Manchester
M8 5RB
United Kingdom
Sponsor information
Organisation
Manchester Mental Health and Social Care Trust (UK)
Sponsor details
c/o Professor Alistair Burns
2nd Floor ERC
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)1612915886
alistair.burns@manchester.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Lundbeck Ltd £53,000 (study grant) plus £5,350 (laboratoty costs) = £58,350
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/sites/pubmed/19370737