Randomised controlled trial of memantine versus placebo in Parkinson's disease dementia
| ISRCTN | ISRCTN32476322 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32476322 |
| Protocol serial number | 3 |
| Sponsor | Manchester Mental Health and Social Care Trust (UK) |
| Funder | Lundbeck Ltd £53,000 (study grant) plus £5,350 (laboratoty costs) = £58,350 |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Park House
North Manchester General Hospital
Delaunay's Road
Crumpsall
Manchester
M8 5RB
United Kingdom
| Phone | +44 (0)1617202497 |
|---|---|
| ILeroi2002@yahoo.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Memantine |
| Primary outcome measure(s) |
Neuropsychological function including measures of: |
| Key secondary outcome measure(s) |
1. Parkinsonian motor symptoms as measured by: |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
M8 5RB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |