[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561849":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":17,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":53,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":17,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":17,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":17,"overallStatus":35,"whyStopped":17,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Istanbul Medipol University Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Alzheimer's Disease Treatment Group","ACTIVE_COMPARATOR","The group will engage with the 40 Hz sensory entrainment-integrated cognitive game kit for one hour a day, five days a week, for three months.",[13],"Device: Sensory Entrainment-Integrated Cognitive Game Kit",{"label":15,"type":16,"description":17,"interventionNames":17},"Alzheimer's Disease Control Group","NO_INTERVENTION",null,{"label":19,"type":16,"description":17,"interventionNames":17},"Healthy Older Adult Group",[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":17},"DEVICE","Sensory Entrainment-Integrated Cognitive Game Kit","Active comparator group will engage with the 40 Hz sensory entrainment-integrated cognitive game kit for one hour a day, at least five days a week, for three months.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":17,"email":31},"Bahar Güntekin, PhD","CONTACT","+90 5326031560","bguntekin@medipol.edu.tr",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":17,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Istanbul Medipol University","RECRUITING","Istanbul","Beykoz","34810","Turkey (Türkiye)",{"type":41,"coordinates":42},"Point",[43,44],28.94966,41.01384,{"lat":44,"lon":43},[47],{"name":28,"role":29,"phone":30,"phoneExt":17,"email":31},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":52,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Bahar Güntekin","Prof. Dr.","Medipol University",[54,56],{"name":55,"class":6},"The Scientific and Technological Research Council of Turkey",{"name":57,"class":6},"Guven Health Group","100561849","effects-of-combined-40-hz-audio-visual-stimulation-and-cognitive-games-on-alzheimers-disease-100561849",false,"NCT06595511","Effects of Combined 40 Hz Audio-visual Stimulation and Cognitive Games on Alzheimer's Disease","Development of a Sensory Entrainment-Integrated Cognitive Game Kit to Improve Cognitive Functions in Alzheimer's Disease","Inclusion and Exclusion Criteria for Alzheimer Patients:\n\nInclusion Criteria:\n\n* Diagnosed with AD according to DSM-IV and NINCDS-ADRDA criteria,\n* Impaired activities of daily living,\n* Having a CDR score of 1-2 and an SMMT score of 15-26,\n* Stable use of psychoactive medications, including acetylcholinesterase inhibitors or other medications that enhance cognitive functions,\n* Individuals aged 60-86 with at least 5 years of education.\n\nExclusion Criteria:\n\n* Having frontotemporal dementia, vascular dementia, Lewy body dementia or other types of dementia,\n* Parkinsonism, clinical depression, other mental disorders, epilepsy, drug addiction, alcohol addiction, and traumatic brain injury\n\nInclusion and Exclusion Criteria of Healthy Older Adults:\n\nInclusion criteria:\n\n* Between the ages of 60-86\n* Without any neurological abnormalities or general cognitive impairment (MMSE above 25),\n* Not diagnosed with a neurological and\u002For psychiatric disease,\n* Not using neurological and\u002For psychiatric medication\n\nExclusion criteria\n\n* Having clinical signs of cognitive impairment, such as mild cognitive impairment, Alzheimer disease, Parkinson disease, Lewy body dementia, frontotemporal dementia, etc.\n* Epilepsy, alcohol and\u002For drug addiction, use of medications that affect cognitive functions, and traumatic brain injury",true,"ALL","60 Years","86 Years",{"count":70,"type":71},30,"ESTIMATED","INTERVENTIONAL",[74],"NA","In addition to ongoing drug treatments for Alzheimer Disease (AD), protective approaches that can halt the progression of the disease are of particular importance. This project aims to develop a digital application that can monitor cognitive impairment, using EEG findings proven effective at the clinical level in Alzheimer and various types of dementia, including sensory entrainment and digital cognitive games.\n\nTo this end, a collaboration between Istanbul Medipol University and Güven Future Health Technologies Inc. will develop a device featuring audio-visual sensory entrainment and digital cognitive games. This device will be made available to Alzheimer patients, and the differences between patients who use the application for three months, patients who do not use the application, and healthy controls will be evaluated through neurological examinations, neuropsychological tests, and EEG recordings indicating cognitive functions by the neurologist, project coordinator, and bursars. Monthly assessments, including EEG recordings, will also continue at home, and an application will be created to evaluate changes in cognitive functions through EEG data.\n\nBy the end of the project, an application that includes sensory entrainment and digital cognitive games, proven effective at the clinical level using EEG findings for Alzheimer dementia patients, will be developed. Additionally, a health kit capable of temporal monitoring of cognitive function changes through EEG data will have been developed.",[77,78,79],"Alzheimer's Disease","40 Hz Stimulation","EEG Brain Oscillations","2024-09-11",{"date":82,"type":83},"2024-09-19","ACTUAL",{"date":85,"type":83},"2022-10-01",{"date":87,"type":71},"2025-04-30",{"name":5,"class":6},1]