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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN 24953404 |
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| Name | Class |
|---|---|
| University of Oxford | OTHER |
| Institute of Psychiatry, London | OTHER |
| University of London | OTHER |
| University College, London |
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We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | Memantine 10mg BD | ||
| Placebo | Drug | Placebo 10 mgs BD |
| Measure | Description | Time Frame |
|---|---|---|
| Cohen-Mansfield | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychiatric Inventory 6+12 weeks | 2 weeks | |
| Clinical Global Impression 6+ 12 weeks | 2 weeks | |
| Severe Impairment Battery 6+12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CHRIS FOX, MBBSBscMSC | KENT AND MEDWAY NHS AND SOCIAL CARE PARTNERSHIP TRUST | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxleas Nhs Foundation Trust | Dartford | KENT | DA2 7WG | United Kingdom | ||
| Kent and Medway NHS and Social Care Partnership Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22567095 | Derived | Fox C, Crugel M, Maidment I, Auestad BH, Coulton S, Treloar A, Ballard C, Boustani M, Katona C, Livingston G. Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial. PLoS One. 2012;7(5):e35185. doi: 10.1371/journal.pone.0035185. Epub 2012 May 2. |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| OTHER |
| Indiana University | OTHER |
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| 2 weeks |
| Quality of Life 6+12 weeks | 2 weeks |
| Co-meds | 2 weeks |
| Incidents of agitation | 2 weeks |
| Use of rescue protocol | 2 weeks |
| Folkestone |
| Kent |
| ct20 1jy |
| United Kingdom |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |