Condition category
Nervous System Diseases
Date applied
30/08/2006
Date assigned
03/10/2006
Last edited
22/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chris Fox

ORCID ID

Contact details

Folkestone Health Centre
15-25 Dover Road
Folkestone
Kent
CT20 1JY
United Kingdom
+44 (0) 1303 228 836
DrChris.Fox@ekentmht.nhs.uk

Additional identifiers

EudraCT number

2005-005087-93

ClinicalTrials.gov number

NCT00371059

Protocol/serial number

EUDRACT-2005-005087-93

Study information

Scientific title

Acronym

MAGD

Study hypothesis

Does memantine have efficacy in agitation for dementia?

Ethics approval

South East Medical Research Ethics Committee will be looking at trial protocol on the 13/9/06 (reference number: 06/MREO1/82).

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Alzheimers Disease

Intervention

Memantine versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Memantine

Primary outcome measures

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 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

Overall trial start date

03/01/2007

Overall trial end date

03/01/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

164

Participant 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)

Recruitment start date

03/01/2007

Recruitment end date

03/01/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Folkestone Health Centre
Kent
CT20 1JY
United Kingdom

Sponsor information

Organisation

East Kent Hospitals Research and Development Committee (UK)

Sponsor details

c/o Dr Art Artionou
Post Graduate Centre
Buckland Hospital
Coombe Valley Road
Dover
CT17 0HB
United Kingdom
+44 (0) 1304 222 561
art.ationu@ekht.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.kentandmedway.nhs.uk/structure_and_organisations/hospital_trusts/east_kent_hospitals_trust.asp

Funders

Funder type

Industry

Funder name

Lundbeck Pharmaceuticals (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22567095

Publication citations

  1. Results

    Fox C, Crugel M, Maidment I, Auestad BH, Coulton S, Treloar A, Ballard C, Boustani M, Katona C, Livingston G, Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial., PLoS ONE, 2012, 7, 5, e35185, doi: 10.1371/journal.pone.0035185.

Additional files

Editorial Notes