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Research Question
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Not provided at time of registration (from ISRCTN)
Additional lay summaries...
We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the
acute situation i.e under 12 weeks
(from ClinicalTrials.gov)
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Ethics Approval
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Sorry, not currently available
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Study Design
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Design Type
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Sorry, not currently available
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Design Details
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Sorry, not currently available
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Health Condition(s) or Problem
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Dementia
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Participants Inclusion Criteria
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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 /=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.
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Participants Exclusion Criteria
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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 /=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.
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Participant Sex
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Sorry, not currently available
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Participant Age Range
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Sorry, not currently available
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Participant Type
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Sorry, not currently available
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Target Sample Size
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164
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Date of First Enrolment
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Sorry, not currently available
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Date of Recruitment End
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Sorry, not currently available
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Date of End of Follow-up
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Sorry, not currently available
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Trial End Date
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Overall Trial Status
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Sorry, not currently available
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Countries of Recruitment
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United Kingdom
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Nation
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England
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Location
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Dartford, Folkestone
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Interventions
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Drug; Memantine; Memantine 10mg BD; Drug; Placebo; Placebo 10 mgs BD
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Primary Outcome Measures
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Cohen-Mansfield
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Secondary Outcome Measures
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Neuropsychiatric Inventory 6+12 weeks; 2 weeks; No; Clinical Global Impression 6+ 12 weeks; 2 weeks; No; Severe Impairment Battery 6+12 weeks; 2 weeks; No; Quality of Life 6+12 weeks; 2 weeks; No; Co-meds; 2 weeks; No; Incidents of agitation; 2 weeks; No; Use of rescue protocol; 2 weeks; Yes
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Website
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Sorry, not currently available
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