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Health Condition(s) or Problem
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Dementia
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Lay Summary
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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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Who can enter the trial
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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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Who cannot enter the trial
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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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What will happen
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Drug; Memantine; Memantine 10mg BD; Drug; Placebo; Placebo 10 mgs BD
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Primary aim
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Cohen-Mansfield
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Secondary Aim
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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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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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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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