Trial record 13 of 698 for:
Open Studies | "Dementia"
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
Recruitment status was Recruiting
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
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
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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:
Detailed Description:
-
Drug: Memantine
Memantine 10mg BD
Drug: Placebo
Placebo 10 mgs BD
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:
- 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
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 Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013