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Memantine for Agitation in Dementia (MAGD)

Primary Purpose

DEMENTIA

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Memantine
Placebo
Sponsored by
East Kent Hospitals University NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for DEMENTIA focused on measuring Agitation, Dementia, Alzheimer's

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Oxleas Nhs Foundation Trust
  • Kent and Medway NHS and Social Care Partnership Trust

Outcomes

Primary Outcome Measures

Cohen-Mansfield

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2006
Last Updated
March 28, 2022
Sponsor
East Kent Hospitals University NHS Foundation Trust
Collaborators
University of Oxford, Institute of Psychiatry, London, University of London, University College, London, Indiana University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00371059
Brief Title
Memantine for Agitation in Dementia
Acronym
MAGD
Official Title
Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 2007 (Actual)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
East Kent Hospitals University NHS Foundation Trust
Collaborators
University of Oxford, Institute of Psychiatry, London, University of London, University College, London, Indiana University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DEMENTIA
Keywords
Agitation, Dementia, Alzheimer's

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
Memantine 10mg BD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 10 mgs BD
Primary Outcome Measure Information:
Title
Cohen-Mansfield
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory 6+12 weeks
Time Frame
2 weeks
Title
Clinical Global Impression 6+ 12 weeks
Time Frame
2 weeks
Title
Severe Impairment Battery 6+12 weeks
Time Frame
2 weeks
Title
Quality of Life 6+12 weeks
Time Frame
2 weeks
Title
Co-meds
Time Frame
2 weeks
Title
Incidents of agitation
Time Frame
2 weeks
Title
Use of rescue protocol
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHRIS FOX, MBBSBscMSC
Organizational Affiliation
KENT AND MEDWAY NHS AND SOCIAL CARE PARTNERSHIP TRUST
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxleas Nhs Foundation Trust
City
Dartford
State/Province
Kent
ZIP/Postal Code
DA2 7WG
Country
United Kingdom
Facility Name
Kent and Medway NHS and Social Care Partnership Trust
City
Folkestone
State/Province
Kent
ZIP/Postal Code
ct20 1jy
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22567095
Citation
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. Epub 2012 May 2.
Results Reference
derived

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Memantine for Agitation in Dementia

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