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| Memantine for the Long Term Management of Neuropsychiatric Symptoms in Alzheimer's disease (MAIN-AD) |
| Source of record | UK Trials |
| ISRCTN | ISRCTN68407918 |
| Date ISRCTN assigned | 14/02/2008 |
| Local reference number(s) | Protocol Version 4, 8/7/2007 |
| Public title | Memantine for the Long Term Management of Neuropsychiatric Symptoms in Alzheimer's disease (MAIN-AD) |
| Scientific title | |
| Acronym | The MAIN-AD Trial |
| Disease/condition/study domain | Alzheimer's disease |
| Study hypothesis | The principal research objective is to investigate the efficacy and safety of memantine when compared to neuroleptics in the long-term management of neuropsychiatric symptoms in people with Alzheimer's disease. |
| Design/methodology | Multi-centre, double-blind, placebo-controlled, double-dummy, parallel-group, randomized controlled trial. |
| Research ethics review | Submitted to the Research Ethics Committee for Wales (Churchill House, 4th Floor, Churchill Way, Cardiff, CF10 2TW, UK), approval pending as of 8 January 2008 (ref: 08/MRE09/5) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Living in a nursing or social care facilities 2. Fulfill the National Institute of Neurological and Communication Disorders and Stroke/ Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for possible or probable Alzheimer's Disease (AD) 3. Taking at least 0.5 mg daily of haloperidol, 0.5 mg daily of risperidone, 5 mg daily of olanzapine or 25 mg daily of quetiapine or another neuroleptic which in the opinion of the responsible clinician could be safely converted to one of these neuroleptics, for a minimum of 3 months prior to entry into the study 4. If taking a cholinesterase inhibitor, prescribed for at least 6 months before the date of assessment, with a stable dose for at least 3 months 5. Not taking anticonvulsants other than carbamazepine or sodium valproate. The use of either of these 2 agents is permissible if the dose has been stable for at least 4 weeks 6. If taking any other psychotropic drugs (e.g., antidepressants, benzodiazepines, chlormethiazole), the dose has been stable for at least 4 weeks prior to randomization 7. Have not received memantine in the last 6 weeks 8. Taking any medications that are contra-indicated or not recommended in combination with memantine, as defined in the British National Formulary, including ketamine, dextromethorphan and amantidine 9. Written informed consent provided by the participant (if they have capacity) and/or their next of kin or a legal representative |
| Participants - exclusion criteria | 1. Current evidence of delirium 2. Moderately severe renal impairment, as measured by or equivalent to an estimated creatinine clearance of <50 mL/min/1.73 m2 3. Severe hepatic impairment 4. Unable to swallow tablets or capsules 5. Low probability of treatment compliance 6. Currently taking memantine 7. Previous evidence of lack of efficacy or tolerability to memantine 8. Taking any of the following substances: 8.1. An investigational drug during the 4 weeks prior to randomization 8.2. A drug known to cause major organ system toxicity during the 4 weeks prior to randomization. 8.3. Started any new psychotropic medication during the 4 weeks prior to randomization. Participants who have been on a stable dose of psychotropic during the 4 weeks prior to randomization are still eligible 8.4. Memantine during the 6 weeks prior to randomization 8.5. Other N-methyl-D-aspartate (NMDA) antagonists: amantadine, ketamine, and dextromethorphan. 8.6. Barbiturates and primidone 8.7. Baclofen and dantrolen 8.8. Dextromethorphan 8.9. Antimuscarinics 8.10. Anticonvulsants other than sodium valproate or carbamazepine. These 2 agents are permissible if doses have been stable for at least 4 weeks |
| Patient information material | Website under construction |
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 01/06/2010 |
| Status of trial | Ongoing |
| Target number of participants | 300 |
| Interventions | Intervention group: Memantine + placebo neuroleptic for 24 weeks Control group: Neuroleptic + placebo memantine for 24 weeks The choice of neuroleptic and dose will be made by the responsible clinician. The neuroleptics allowed are haloperidol, risperidone, olanzapine and quetiapine. |
| Primary outcome measure(s) | The following will be assessed at baseline, week 6, week 12 and week 24: 1. Bristol Activities of Daily Living scale. Please note that only the week 24 outcome will be considered as the primary outcome. 2. Cohen-Mansfield agitation inventory. |
| Secondary outcome measure(s) | The following will be assessed at baseline, week 6, week 12 and week 24: 1. Neuropsychiatric inventory 2. Severe impairment battery 3. Mini-mental state examination 4. Letter fluency (FAS) test 5. Functional assessment staging 6. Modified D test 7. Clinical global impression of change 8. Modified unified Parkinson's disease rating scale 9. Abnormal involuntary movement scale |
| Sources of funding | Lundbeck Pharmaceutical. Contact: Dr Ya'acov Leigh, Lundbeck House, Caldecotte Lake Business Park, Caldecotte, Milton Keynes, MK7 8LG, UK. E-mail: YALE@lundbeck.com |
| Sponsor name | King's College London (UK) |
| Sponsor details | Hodkin Building Guy's Campus London United Kingdom SE1 1UL |
| Sponsor website | http://kcl.ac.uk |
| Contact name | Prof Clive Ballard |
| Contact details | Wolfson Centre for Age-Related Diseases Wolfson Wing Hodkin Building King's College London Guy's Campus London United Kingdom SE1 1UL |
| Contact telephone | +44 20 7848 8054 |
| Contact fax | +44 20 7848 6569 |
| Contact email | clive.ballard@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN68407918 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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