Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-04 @ 9:13 AM
Study NCT ID:
NCT04114994
Status:
RECRUITING
Last Update Posted:
2024-08-01
First Post:
2019-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Cognitive Assessment by BoCA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D057180', 'term': 'Frontotemporal Dementia'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2029-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2019-10-02', 'studyFirstSubmitQcDate': '2019-10-02', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boston Cognitive Assessment (BoCA)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease', 'Mild Cognitive Impairment', 'Vascular Dementia', 'Frontotemporal Dementia', 'Parkinson Disease', 'Multiple Sclerosis', 'TBI']}, 'referencesModule': {'references': [{'pmid': '31534026', 'type': 'BACKGROUND', 'citation': 'Foster NL, Bondi MW, Das R, Foss M, Hershey LA, Koh S, Logan R, Poole C, Shega JW, Sood A, Thothala N, Wicklund M, Yu M, Bennett A, Wang D. Quality improvement in neurology: Mild cognitive impairment quality measurement set. Neurology. 2019 Oct 15;93(16):705-713. doi: 10.1212/WNL.0000000000008259. Epub 2019 Sep 18. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://boca.alz.life', 'label': 'BoCA website'}]}, 'descriptionModule': {'briefSummary': 'The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.', 'detailedDescription': "The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not- repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.\n\nBoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance.\n\nAfter BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.\n\nThe BoCA evaluation can help doctors figure out if an underlying condition is causing a patient's cognitive decline. Many treatable conditions such as sleep disorders, mood problems, heavy metal accumulation, as well as lack of movement and social interactions can affect memory and thinking.\n\nOur goal is to reduce barriers for patients to receive the testing that may benefit their treatment and health through the use of digital technology."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "According to the American Academy of Neurology, nearly 7% of people in their early 60s worldwide have mild cognitive impairment, while the condition affects 38% of people ages 85 and older.\n\nThe BoCA evaluation can help doctors figure out if an underlying condition is causing a patient's cognitive decline. Many treatable conditions such as sleep disorders, mood problems, heavy metal accumulation, as well as lack of movement and social interactions can affect memory and thinking.\n\nOur goal is to reduce barriers for patients to receive the testing that may benefit their treatment and health through the use of digital technology.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nage 50 or older\n\nExclusion Criteria:\n\nyounger than 50 years'}, 'identificationModule': {'nctId': 'NCT04114994', 'acronym': 'BoCA', 'briefTitle': 'Longitudinal Cognitive Assessment by BoCA', 'organization': {'class': 'INDUSTRY', 'fullName': "Alzheimer's Light LLC"}, 'officialTitle': 'Longitudinal Cognitive Assessment by BoCA', 'orgStudyIdInfo': {'id': 'BoCA001'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Alzheimer's Disease", 'interventionNames': ['Diagnostic Test: Boston Cognitive Assessment (BoCA)']}, {'label': 'Mild Cognitive Impairment', 'interventionNames': ['Diagnostic Test: Boston Cognitive Assessment (BoCA)']}, {'label': 'Frontotemporal Dementia', 'interventionNames': ['Diagnostic Test: Boston Cognitive Assessment (BoCA)']}, {'label': 'Vascular Dementia', 'interventionNames': ['Diagnostic Test: Boston Cognitive Assessment (BoCA)']}, {'label': 'Parkinson Disease', 'interventionNames': ['Diagnostic Test: Boston Cognitive Assessment (BoCA)']}, {'label': 'Traumatic Brain Injury (TBI)', 'interventionNames': ['Diagnostic Test: Boston Cognitive Assessment (BoCA)']}, {'label': 'Multiple Sclerosis', 'interventionNames': ['Diagnostic Test: Boston Cognitive Assessment (BoCA)']}, {'label': 'No diagnosis', 'interventionNames': ['Diagnostic Test: Boston Cognitive Assessment (BoCA)']}], 'interventions': [{'name': 'Boston Cognitive Assessment (BoCA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.\n\nBoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance.\n\nAfter BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts.', 'armGroupLabels': ["Alzheimer's Disease", 'Frontotemporal Dementia', 'Mild Cognitive Impairment', 'Multiple Sclerosis', 'No diagnosis', 'Parkinson Disease', 'Traumatic Brain Injury (TBI)', 'Vascular Dementia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33156', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrey Vyshedskiy', 'role': 'CONTACT', 'email': 'vysha@bu.edu', 'phone': '617-433-8577'}], 'facility': 'Andrey Vyshedskiy', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'ANDREY VYSHEDSKIY, Ph.D.', 'role': 'CONTACT', 'email': 'vysha@bu.edu', 'phone': '6174338577'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Alzheimer's Light LLC", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}