Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-26 @ 5:22 AM
Study NCT ID:
NCT00371059
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2006-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Memantine for Agitation in Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D011595', 'term': 'Psychomotor Agitation'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2006-08-30', 'studyFirstSubmitQcDate': '2006-08-30', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohen-Mansfield', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Neuropsychiatric Inventory 6+12 weeks', 'timeFrame': '2 weeks'}, {'measure': 'Clinical Global Impression 6+ 12 weeks', 'timeFrame': '2 weeks'}, {'measure': 'Severe Impairment Battery 6+12 weeks', 'timeFrame': '2 weeks'}, {'measure': 'Quality of Life 6+12 weeks', 'timeFrame': '2 weeks'}, {'measure': 'Co-meds', 'timeFrame': '2 weeks'}, {'measure': 'Incidents of agitation', 'timeFrame': '2 weeks'}, {'measure': 'Use of rescue protocol', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Agitation', 'Dementia', "Alzheimer's"], 'conditions': ['DEMENTIA']}, 'referencesModule': {'references': [{'pmid': '22567095', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance.\n2. Alzheimer's Disease only as per McKhann Criteria + Hachinski Score\\<=4.\n3. Moderately severe to severe Alzheimer's Disease (baseline MMSE \\</=19).\n4. Clinically significant agitation that requires treatment.\n5. Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) \\> /=45.\n6. Age \\>/= 55.\n\nExclusion Criteria:\n\n1. Memantine usage in the 4 weeks prior to the start of the study.\n2. On Cholinesterase inhibitor for less than 3 months and not on a stable dose.\n3. Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study.\n4. Antiparkinsonian medication.\n5. Hypersensitivity to memantine or any of the excipients in the formulation.\n6. Severe renal impairment.\n7. Epilepsy, history of convulsions or seizure, or receiving any anti-epileptic treatment.\n8. Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan.\n9. Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension.\n10. Severe, unstable or poorly controlled medical illness.\n11. Any disability that may interfere with the patient completing the study procedure.\n12. Active malignancy.\n13. Delirium, pain or any medical illness as a clear cause of agitation.\n14. 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."}, 'identificationModule': {'nctId': 'NCT00371059', 'acronym': 'MAGD', 'briefTitle': 'Memantine for Agitation in Dementia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'East Kent Hospitals University NHS Foundation Trust'}, 'officialTitle': 'Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia', 'orgStudyIdInfo': {'id': '2005-005087-93'}, 'secondaryIdInfos': [{'id': 'ISRCTN 24953404'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Memantine', 'type': 'DRUG', 'description': 'Memantine 10mg BD'}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 10 mgs BD'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DA2 7WG', 'city': 'Dartford', 'state': 'KENT', 'country': 'United Kingdom', 'facility': 'Oxleas Nhs Foundation Trust', 'geoPoint': {'lat': 51.44657, 'lon': 0.21423}}, {'zip': 'ct20 1jy', 'city': 'Folkestone', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Kent and Medway NHS and Social Care Partnership Trust', 'geoPoint': {'lat': 51.08169, 'lon': 1.16734}}], 'overallOfficials': [{'name': 'CHRIS FOX, MBBSBscMSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KENT AND MEDWAY NHS AND SOCIAL CARE PARTNERSHIP TRUST'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Kent Hospitals University NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'Institute of Psychiatry, London', 'class': 'OTHER'}, {'name': 'University of London', 'class': 'OTHER'}, {'name': 'University College, London', 'class': 'OTHER'}, {'name': 'Indiana University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}