Memantine for Agitation in Dementia (MAGD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by East Kent Hospitals University NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Oxford
Institute of Psychiatry, London
University of London
University College, London
Indiana University School of Medicine
Information provided by:
East Kent Hospitals University NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00371059
First received: August 30, 2006
Last updated: May 7, 2008
Last verified: May 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 University NHS Foundation 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Oxleas Nhs Foundation Trust Recruiting
Dartford, Kent, United Kingdom, DA2 7WG
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 University NHS Foundation 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 by East Kent Hospitals University NHS Foundation Trust

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

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

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

ClinicalTrials.gov processed this record on August 28, 2014