Memantine for Agitation in Dementia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia

Conditions
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DEMENTIA

Intervention / Treatment
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* Drug: Memantine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance. Alzheimer's Disease only as per McKhann Criteria + Hachinski Score<=4. Moderately severe to severe Alzheimer's Disease (baseline MMSE </=19). Clinically significant agitation that requires treatment. Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) > /=45. Age >/= 55. Exclusion Criteria: Memantine usage in the 4 weeks prior to the start of the study. On Cholinesterase inhibitor for less than 3 months and not on a stable dose. Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study. Antiparkinsonian medication. Hypersensitivity to memantine or any of the excipients in the formulation. Severe renal impairment. Epilepsy, history of convulsions or seizure, or receiving any anti-epileptic treatment. Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan. Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension. Severe, unstable or poorly controlled medical illness. Any disability that may interfere with the patient completing the study procedure. Active malignancy. Delirium, pain or any medical illness as a clear cause of agitation. 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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Memantine|Memantine 10mg BD|
|Drug: Placebo|Placebo 10 mgs BD|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen-Mansfield |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Agitation, Dementia, Alzheimer's