Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-22 @ 8:59 AM
Study NCT ID:
NCT01885806
Status:
UNKNOWN
Last Update Posted:
2013-06-25
First Post:
2013-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D053609', 'term': 'Lethargy'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-24', 'studyFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2013-06-24', 'lastUpdatePostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety assessment', 'timeFrame': '4th week, 8th week, 12th week', 'description': 'Assessment of rTMS safety by the UKU scale.'}], 'primaryOutcomes': [{'measure': 'Change in apathy symptoms', 'timeFrame': '12 weeks', 'description': 'Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment.'}], 'secondaryOutcomes': [{'measure': 'Change in ADAS-Cog scores', 'timeFrame': '12 weeks', 'description': 'Improvement in ADAS-Cog scores between baseline and 12 weeks after treatment.'}, {'measure': 'Change in the Zarit Burden Scale', 'timeFrame': '12 weeks', 'description': 'Reduction in the Zarit Burden Scale between baseline and 12 weeks after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Apathy; Alzheimer's disease; Cognition; Burden of Care"], 'conditions': ["Alzheimer's Disease", 'Apathy']}, 'descriptionModule': {'briefSummary': "We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.", 'detailedDescription': "This study aims to enroll 40 patients with mild and moderate Alzheimer's disease with apathy symptoms that will be randomized to receive rTMS or sham procedure. Subjects will be randomized in two arms (rTMS or sham procedure) in 1:1 proportion.\n\nEligibility criteria:\n\n* Diagnosis of Alzheimer's disease, mild and moderate stage (MMSE range from 10 to 20);\n* Diagnosis of apathy;\n* age between 60 and 85 years-old;\n* On stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment;\n\nThe primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 60 to 85 years-old\n* Mild or moderate Alzheimer's disease (MMSE scores between 10 and 20)\n* Apathy diagnosis\n* On stable doses of cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 6 months prior to enrollment\n\nExclusion Criteria:\n\n* history of epilepsy or convulsions\n* History of migraine or headaches episodes twice per week or more\n* History of neurodegenerative diseases other than Alzheimer's disease\n* Current use of first generation antipsychotics, clozapine, tricyclic drugs or anticonvulsants\n* History of cerebral ischemic episode"}, 'identificationModule': {'nctId': 'NCT01885806', 'briefTitle': "Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': "Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease: a Randomised, Double-blind, Controlled Study", 'orgStudyIdInfo': {'id': 'CAAE: 15388913.6.0000.5149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Repetitive TMS', 'description': 'Patients will receive 10 consecutive sessions of repetitive transcranial magnetic stimulation with the following protocol:\n\nFrequency: 10 Hz Intensity: 90% motor limiar Session duration: 16 minutes (20 sequencies of 6 seconds of stimulation followed by intervals of 30 seconds); Localization: Left pre-frontal dorsolateral cortex;', 'interventionNames': ['Device: Magnetic Stimulator Magstim Rapid 2']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham TMS', 'description': 'Patients will receive 10 consecutive sessions of sham transcranial magnetic stimulation following the same protocol as the intervention arm, but with no magnetic stimulation of the brain.', 'interventionNames': ['Device: Sham Magnetic Stimulator']}], 'interventions': [{'name': 'Magnetic Stimulator Magstim Rapid 2', 'type': 'DEVICE', 'otherNames': ['rTMS'], 'description': 'All procedures will use the Magnetic Stimulator Magstim Rapid 2. Total of session: 10 rTMS protocol: Freqüency: 10 Hz Intensity: 90% limiar motor Session duration: 16 minutes (20 TMS sequences of 6 second with intervals of 30 seconds between each sequence) Location: Left dorsolateral pre-frontal cortex', 'armGroupLabels': ['Repetitive TMS']}, {'name': 'Sham Magnetic Stimulator', 'type': 'DEVICE', 'otherNames': ['Sham'], 'description': 'This intervention will follow the same protocol of the rTMS except that subjects will not receive magnetic stimulation of the brain.\n\nTotal of session: 10', 'armGroupLabels': ['Sham TMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Outside of U.S.', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marco A Romano-Silva, MD, PhD', 'role': 'CONTACT', 'email': 'romanosilva@gmail.com', 'phone': '+55 31 3409-9758'}, {'name': 'Breno S Diniz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Federal University of Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Outside of U.S.', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marco A Romano-Silva, MD, PhD', 'role': 'CONTACT', 'email': 'romanosilva@gmail.com', 'phone': '+55 31 3409-9785'}, {'name': 'Breno S Diniz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Federal University of Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}], 'centralContacts': [{'name': 'Breno S Diniz, MD, PhD', 'role': 'CONTACT', 'email': 'brenosatler@gmail.com', 'phone': '+55 31 97950860'}], 'overallOfficials': [{'name': 'Breno S Diniz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Minas Gerais'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Breno Satler de Oliveira Diniz', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}