Memantine for AGitation in Dementia
| ISRCTN | ISRCTN24953404 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24953404 |
| EudraCT/CTIS number | 2005-005087-93 |
| ClinicalTrials.gov number | NCT00371059 |
| Secondary identifying numbers | EUDRACT-2005-005087-93 |
- Submission date
- 30/08/2006
- Registration date
- 03/10/2006
- Last edited
- 22/10/2012
- 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 Chris Fox
Scientific
Scientific
Folkestone Health Centre
15-25 Dover Road
Folkestone
Kent
CT20 1JY
United Kingdom
| Phone | +44 (0) 1303 228 836 |
|---|---|
| DrChris.Fox@ekentmht.nhs.uk |
Study information
| Study design | Pragmatic randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | MAGD |
| Study objectives | Does memantine have efficacy in agitation for dementia? |
| Ethics approval(s) | South East Medical Research Ethics Committee will be looking at trial protocol on the 13/9/06 (reference number: 06/MREO1/82). |
| Health condition(s) or problem(s) studied | Alzheimers Disease |
| Intervention | Memantine versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Memantine |
| Primary outcome measure | CMAI at six weeks. |
| Secondary outcome measures | 1. NeuroPsychiatric Inventory (NPI) score at six and 12 weeks 2. CMAI score at 12 weeks 3. Clinical Global Impressions (CGI) scale and Scales of Independent Behavior (SIB) score at six and 12 weeks .4 Quality of Life scale in Alzheimers Disease (QOL-AD) at six and 12 weeks 5. Use of co-prescribed medication 6. Occasions of need to use trial rescue protocol mechanism of keeping patients in the trial during dose titration period up to week three |
| Overall study start date | 03/01/2007 |
| Completion date | 03/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 164 |
| Key inclusion criteria | 1. Residential/inpatients 2. Alzheimers-McKhann Criteria and Haschinski less than four 3. Mini-Mental State Examination (MMSE) score less than or equal to 19 4. Clinically significant agitation requiring treatment 5. Cohen-Mansfield Agitation Inventory (CMAI) score more than or equal to 45 6. Aged 55 years or more |
| Key exclusion criteria | 1. Memantine use in four weeks prior 2. On cholinesterase inhibitors for less than three months and dose not stable 3. Anti-psychotic, antibiotic, anti-epileptic, anti-depressant, benzodiazepine, lithium, or hypnotic dose alteration in two weeks prior to start 4. Antiparkinsonsian medication 5. Hypersensitivity to memantine or components 6. Severe renal impairment 7. Epilepsy, history of convulsions or seizure, or receiving anti-epileptics 8. Concomitant usage of N-Methyl-D-Aspartic acid (NMDA) antagonists amantadine, ketamine, dextromethorphan 9. Recent Myocardial Infarction (MI), uncompensated Congestive Cardiac Failure (CCF) and uncontrolled hypertension 10. Severe, unstable or poorly controlled medical illness 11. Disability which affects ability to complete study 12. Active malignancy 13. Delirium, pain or medical illness as a cause of agitation 14. Any important drug interactions prohibited during study and in 14 days prior: analgesic (dextromethorpan), dopaminergics (amantadine, warfarin) |
| Date of first enrolment | 03/01/2007 |
| Date of final enrolment | 03/01/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Folkestone Health Centre
Kent
CT20 1JY
United Kingdom
CT20 1JY
United Kingdom
Sponsor information
East Kent Hospitals Research and Development Committee (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Art Artionou
Post Graduate Centre
Buckland Hospital
Coombe Valley Road
Dover
CT17 0HB
England
United Kingdom
| Phone | +44 (0) 1304 222 561 |
|---|---|
| art.ationu@ekht.nhs.uk | |
| Website | http://www.kentandmedway.nhs.uk/structure_and_organisations/hospital_trusts/east_kent_hospitals_trust.asp |
"ROR" |
https://ror.org/02dqqj223 |
Funders
Funder type
Industry
Lundbeck Pharmaceuticals (UK)
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 | 01/06/2012 | Yes | No |
