MAGD: Memantine for Agitation in Dementia

Sponsor

East Kent Hospitals University NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00371059

Collaborator

University of Oxford (Other), Institute of Psychiatry, London (Other), University of London (Other), University College, London (Other), Indiana University School of Medicine (Other)

153

Enrollment

Locations

Actual Duration (Months)

76.5

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
DEMENTIA	Drug: Memantine Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

153 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia

Actual Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Outcome Measures

Primary Outcome Measures

Cohen-Mansfield [2 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oxleas Nhs Foundation Trust	Dartford	Kent	United Kingdom	DA2 7WG
2	Kent and Medway NHS and Social Care Partnership Trust	Folkestone	Kent	United Kingdom	ct20 1jy