Memantine for AGitation in Dementia

Completed

• Conditions: Alzheimers Disease; Nervous System Diseases

• Registration Number: ISRCTN24953404
• Lead Sponsor: East Kent Hospitals Research and Development Committee (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 164

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CMAI at six weeks.

Secondary Outcome Measures

Name	Time	Method
1. NeuroPsychiatric Inventory (NPI) score at six and 12 weeks<br>2. CMAI score at 12 weeks<br>3. Clinical Global Impressions (CGI) scale and Scales of Independent Behavior (SIB) score at six and 12 weeks<br>.4 Quality of Life scale in Alzheimer?s Disease (QOL-AD) at six and 12 weeks<br>5. Use of co-prescribed medication<br>6. Occasions of need to use trial rescue protocol mechanism of keeping patients in the trial during dose titration period up to week three