Memantine for Agitation in Dementia

Phase 4

Completed

• Conditions: DEMENTIA

• Registration Number: NCT00371059
• Lead Sponsor: East Kent Hospitals University NHS Foundation Trust

Brief Summary

We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks

Detailed Description

Agitation is a cause of morbidity and mortality in Alzheimer's due to distress and use of medication with side effects. Memantine has beed shown to be associated with less agitation and a recent study by forrest pharmaceuticals failed to recruit. We will perform a 12 week rct in 164 patients to test this hypothesis in a locality with no competing studies and in a clinical setting where the drug is not often used. We will compare with placebo and also use a rescue protocol derived from international best practice.

Study Timeline

• Study First Submitted: 2006-08-30
• Study First Submitted QC: 2006-08-30
• Study First Posted: 2006-09-01
• Study Start: 2007-09
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

1. Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance.
2. Alzheimer's Disease only as per McKhann Criteria + Hachinski Score<=4.
3. Moderately severe to severe Alzheimer's Disease (baseline MMSE </=19).
4. Clinically significant agitation that requires treatment.
5. Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) > /=45.
6. Age >/= 55.

Exclusion Criteria

1. Memantine usage in the 4 weeks prior to the start of the study.
2. On Cholinesterase inhibitor for less than 3 months and not on a stable dose.
3. Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study.
4. Antiparkinsonian medication.
5. Hypersensitivity to memantine or any of the excipients in the formulation.
6. Severe renal impairment.
7. Epilepsy, history of convulsions or seizure, or receiving any anti-epileptic treatment.
8. Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan.
9. Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension.
10. Severe, unstable or poorly controlled medical illness.
11. Any disability that may interfere with the patient completing the study procedure.
12. Active malignancy.
13. Delirium, pain or any medical illness as a clear cause of agitation.
14. Any important drug interactions: Prohibited during study and in the 14 days preceding enrollment/inclusion are: Analgesic dextromethorphan, Dopaminergics- amantadine, Warfarin due to theoretical INR prolongation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cohen-Mansfield	2 weeks

Secondary Outcome Measures

Name	Time	Method
Neuropsychiatric Inventory 6+12 weeks	2 weeks
Clinical Global Impression 6+ 12 weeks	2 weeks
Severe Impairment Battery 6+12 weeks	2 weeks
Quality of Life 6+12 weeks	2 weeks
Co-meds	2 weeks
Incidents of agitation	2 weeks
Use of rescue protocol	2 weeks

Trial Locations

Locations (2)

Oxleas Nhs Foundation Trust; 🇬🇧 Dartford, Kent, United Kingdom

Kent and Medway NHS and Social Care Partnership Trust; 🇬🇧 Folkestone, Kent, United Kingdom