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| [ ...Back to search results ] | [ Print-friendly version ] |
| Randomised controlled trial of memantine versus placebo in Parkinson's disease dementia |
| ISRCTN | ISRCTN32476322 |
| ClinicalTrials.gov identifier | |
| Public title | Randomised controlled trial of memantine versus placebo in Parkinson's disease dementia |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 3 |
| Study hypothesis | To investigate the safety and efficacy of memantine used for treatment of cognitive and functional impairment in Parkinson's disease. |
| Lay summary | |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Parkinson's disease dementia |
| Participants - inclusion criteria |
1. Male and female patients, minimum age of 50.
2. Have a clinical diagnosis of idiopathic Parkinson’s disease (PD) according to the UK Parkinson’s 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). |
| Participants - 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. |
| Anticipated start date | 01/01/2005 |
| Anticipated end date | 01/01/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 50 |
| Interventions | Memantine, a new glutamatergic modulator used for treatment of cognitive and functional impairment in Alzheimer disease versus placebo. |
| Primary outcome measure(s) |
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 measure(s) |
1. Parkinsonian motor symptoms as measured by:
1.1. The Unified Parkinson’s 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 Parkinson’s Disease Questionnaire (PDQ-39) (Jenkinson et al., 1998). 4. Global measure of change as assessed by the Clinician’s Interview Based Impression of Change (CIBIC+). |
| Sources of funding | Lundbeck Ltd £53,000 (study grant) plus £5,350 (laboratoty costs) = £58,350 |
| Trial website | |
| Publications | 2009 results in http://www.ncbi.nlm.nih.gov/sites/pubmed/19370737 |
| Contact name | Dr Iracema Leroi |
| Address |
Park House
North Manchester General Hospital Delaunay's Road Crumpsall |
| City/town | Manchester |
| Zip/Postcode | M8 5RB |
| Country | United Kingdom |
| Tel | +44 (0)1617202497 |
| Fax | +44 (0)1617202771 |
| ILeroi2002@yahoo.co.uk | |
| Sponsor | Manchester Mental Health and Social Care Trust (UK) |
| Address |
c/o Professor Alistair Burns
2nd Floor ERC Wythenshawe Hospital Southmoor Road |
| City/town | Manchester |
| Zip/Postcode | M23 9LT |
| Country | United Kingdom |
| Tel | +44 (0)1612915886 |
| Fax | +44 (0)1612915882 |
| alistair.burns@manchester.ac.uk | |
| Date applied | 08/09/2005 |
| Last edited | 05/08/2009 |
| Date ISRCTN assigned | 14/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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