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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 |
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Information provided by: | East Kent Hospitals Trust |
ClinicalTrials.gov Identifier: | NCT00371059 |
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 |
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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 |
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) |
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.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: CHRIS FOX, MBBSBscMsc | 44-130-322-8836 | DrChris.Fox@ekentmht.nhs.uk |
Contact: ADRIAN TRELOAR, MB BS Bsc | 44-132-262-5700 |
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 |
Principal Investigator: | CHRIS FOX, MBBSBscMSC | KENT AND MEDWAY NHS AND SOCIAL CARE PARTNERSHIP TRUST |
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 |
Agitation Dementia Alzheimer's |
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 |
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 |