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Memantine for Agitation in Dementia (MAGD)
This study is currently recruiting participants.
Verified by East Kent Hospitals Trust, May 2008
First Received: August 30, 2006   Last Updated: May 7, 2008   History of Changes
Sponsors and Collaborators: East Kent Hospitals Trust
University of Oxford
Institute of Psychiatry, London
University of London
University College, London
Indiana University School of Medicine
Information provided by: East Kent Hospitals Trust
ClinicalTrials.gov Identifier: NCT00371059
  Purpose

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 Intervention Phase
Dementia
Drug: Memantine
Drug: Placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia

Resource links provided by NLM:


Further study details as provided by East Kent Hospitals Trust:

Primary Outcome Measures:
  • Cohen-Mansfield [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychiatric Inventory 6+12 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression 6+ 12 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Severe Impairment Battery 6+12 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Quality of Life 6+12 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Co-meds [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Incidents of agitation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Use of rescue protocol [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 164
Study Start Date: September 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Memantine
    Memantine 10mg BD
    Drug: Placebo
    Placebo 10 mgs BD
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371059

Contacts
Contact: CHRIS FOX, MBBSBscMsc 44-130-322-8836 DrChris.Fox@ekentmht.nhs.uk
Contact: ADRIAN TRELOAR, MB BS Bsc 44-132-262-5700

Locations
United Kingdom, KENT
Oxleas Nhs Foundation Trust Recruiting
DARTFORD, KENT, United Kingdom, DA2 7WG
United Kingdom, Kent
Kent and Medway NHS and Social Care Partnership Trust Recruiting
folkestone, Kent, United Kingdom, ct20 1jy
Sub-Investigator: MONICA CRUGEL, MRCPSYCH            
Sponsors and Collaborators
East Kent Hospitals Trust
University of Oxford
Institute of Psychiatry, London
University of London
University College, London
Indiana University School of Medicine
Investigators
Principal Investigator: CHRIS FOX, MBBSBscMSC KENT AND MEDWAY NHS AND SOCIAL CARE PARTNERSHIP TRUST
  More Information

No publications provided

Responsible Party: EAST KENT HOSPITALS TRUST ( DR ART ATIONU )
Study ID Numbers: 2005-005087-93, ISRCTN 24953404
Study First Received: August 30, 2006
Last Updated: May 7, 2008
ClinicalTrials.gov Identifier: NCT00371059     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by East Kent Hospitals Trust:
Agitation
Dementia
Alzheimer's

Study placed in the following topic categories:
Excitatory Amino Acids
Neurotransmitter Agents
Central Nervous System Diseases
Psychomotor Agitation
Brain Diseases
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dopamine
Mental Disorders
Memantine
Dopamine Agents
Dementia
Delirium

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Central Nervous System Diseases
Excitatory Amino Acid Agents
Brain Diseases
Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Memantine
Dopamine Agents
Dementia
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on September 09, 2009