Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-01 @ 12:50 PM
Study NCT ID:
NCT03661034
Status:
UNKNOWN
Last Update Posted:
2021-08-24
First Post:
2018-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
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': 'D008569', 'term': 'Memory Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'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': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multi-center, four-arm prospective dose-adjusting study (2 cohorts sequentially enrolled, each with 2 randomly assigned dose levels)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-09-04', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Amyloid Positron Emission Tomography (PET) Scan', 'timeFrame': 'PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month)', 'description': 'Movement of amyloid, as measured qualitatively and quantitatively in Amyloid PET Imaging at 0, 1.5, 3, 6, 9 and 12 months following assigned regimen of sensory stimulation treatment sessions'}, {'measure': 'Adverse Events', 'timeFrame': 'Over 12 months', 'description': 'Composite adverse events to be assessed at Interim Analysis (at any point in partial study completion), and final analysis (at 6 and 12 months time points).'}], 'secondaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)", 'timeFrame': 'Baseline, 3, 6, 9 and 12 months', 'description': 'A scale used to assess cognition; This scale consists of 14 questions assessed resulting in a score from 0 to 90, where a higher score indicates more cognitive disruption.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Dementia', "Alzheimer's Disease", 'Memory Loss'], 'conditions': ['Alzheimer Disease, Early Onset', 'Alzheimer Disease', 'Alzheimer Dementia', 'Mild Cognitive Impairment', 'Memory Disorders', 'Memory Loss', 'Memory Impairment', 'Memory Disorders, Age Related', 'Alzheimer Disease, Late Onset', 'Cognitive Impairment', 'Dementia, Mild', 'Dementia, Alzheimer Type', 'Cognitive Decline']}, 'descriptionModule': {'briefSummary': 'The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.', 'detailedDescription': 'Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\>= 50 Years Old\n* MMSE 24 - 30\n* Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD\n* Participation of a caregiver / care partner\n* Amyloid Positive PET Scan\n\nExclusion Criteria:\n\n* Profound hearing or visual impairment\n* Seizure Disorder\n* Use of memantine (Namenda or Namzaric)\n* Implantable devices (non-MR compatible)"}, 'identificationModule': {'nctId': 'NCT03661034', 'briefTitle': 'Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cognito Therapeutics, Inc.'}, 'officialTitle': 'Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)', 'orgStudyIdInfo': {'id': 'CA-0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Arm A', 'description': 'Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk)', 'interventionNames': ['Device: GammaSense Stimulation System (non-invasive, non-significant risk)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Arm B', 'description': 'Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk)', 'interventionNames': ['Device: GammaSense Stimulation System (non-invasive, non-significant risk)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Arm C', 'description': 'Dosing 1 hour session every other day or one 2 hour session per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk)', 'interventionNames': ['Device: GammaSense Stimulation System (non-invasive, non-significant risk)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Arm D', 'description': 'Dosing 30 minute session twice per day or 120 minute session twice per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk)', 'interventionNames': ['Device: GammaSense Stimulation System (non-invasive, non-significant risk)']}], 'interventions': [{'name': 'GammaSense Stimulation System (non-invasive, non-significant risk)', 'type': 'DEVICE', 'otherNames': ['FG-0003'], 'description': 'Non-invasive, non-significant risk audio-visual sensory stimulation device', 'armGroupLabels': ['Cohort 1, Arm A', 'Cohort 1, Arm B', 'Cohort 2, Arm C', 'Cohort 2, Arm D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02459', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Center for Memory', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}], 'overallOfficials': [{'name': 'Evan R Hempel', 'role': 'STUDY_CHAIR', 'affiliation': 'Cognito Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cognito Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}