Memantine for AGitation in Dementia

ISRCTN ISRCTN24953404
DOI https://doi.org/10.1186/ISRCTN24953404
ClinicalTrials.gov (NCT) NCT00371059
Clinical Trials Information System (CTIS) 2005-005087-93
Protocol serial number EUDRACT-2005-005087-93
Sponsor East Kent Hospitals Research and Development Committee (UK)
Funder Lundbeck Pharmaceuticals (UK)
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

Folkestone Health Centre
15-25 Dover Road
Folkestone
Kent
CT20 1JY
United Kingdom

+44 (0) 1303 228 836
DrChris.Fox@ekentmht.nhs.uk

Study information

Primary study designInterventional
Study designPragmatic randomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymMAGD
Study objectivesDoes 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) studiedAlzheimers Disease
InterventionMemantine versus placebo
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Memantine
Primary outcome measure(s)

CMAI at six weeks.

Key secondary outcome measure(s)

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 Alzheimer’s 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

Completion date03/01/2009

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target sample size at registration164
Key inclusion criteria1. 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 criteria1. 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 enrolment03/01/2007
Date of final enrolment03/01/2009

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Folkestone Health Centre
Kent
CT20 1JY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
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