Nctid:
NCT06615167
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003704", "term"=>"Dementia"}, {"id"=>"D000019965", "term"=>"Neurocognitive Disorders"}], "ancestors"=>[{"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M6904", "name"=>"Dementia", "asFound"=>"Dementia", "relevance"=>"HIGH"}, {"id"=>"M21836", "name"=>"Neurocognitive Disorders", "asFound"=>"Neurocognitive Disorders", "relevance"=>"HIGH"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE", "maskingDescription"=>"In this study, there will be two data analysts involved. Analyst 1 will be responsible for analyzing the results generated by the ALZGUARD application, which are based on the ALZGUARD AI model. This analyst will assess whether each subject has dementia and the likelihood or probability of the diagnosis. Analyst 1 will be blinded to any clinical assessments or dianoses made by the neurologists."}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"This is a single-arm, interventional clinical trial designed to evlauate the efficacy and safety of ALZGAURD, a smartphone-based digital therapeutic, in detecting dementia.\n\nStudy type: interentional (clinical trial) Masking: Single-blind (Outcomes assessor) Intervention description: The ALZGUARD application will be used by participants to assess cognitive function. Results will be compared to clinical diagnoses made by neurologists.\n\nPrimary Outcome: the accuracy of the ALZGUARD diagnosis, measured by Area Under the Curve."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>122}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-12", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-04-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-20", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-04-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Area Under the Curve (AUC)", "timeFrame"=>"up to 8 months", "description"=>"The primary outcome will be the Area Under the Curve (AUC), which will assess the diagnostic accuracy of ALZGUARD by comparing its results with the clinical diagnosis made by neurologists. AUC will be calculated to determine the performance of ALZGUARD in detecting dementia."}], "secondaryOutcomes"=>[{"measure"=>"Sensitivity", "timeFrame"=>"up to 8 months", "description"=>"The one of the secondary outcome will measure the sensitivity of ALZGUARD in detecting dementia. Sensitivity refers to the proportion of true positive cases accurately identified by ALZGUARD, compared to clinical diagnosis made by neurologists. This measure will assess the ability of ALZGUARD to correctly identiry patients who have dementia."}, {"measure"=>"Specificity", "timeFrame"=>"up to 8 months", "description"=>"Specificity refers to the proportion of true negative cases accurately identified by ALZGUARD, compared to the clinical diagnosis made by neurologists. This outcome will assess the ability of ALZGUARD to correctly identify patient who do not have dementia."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Dementia", "Major Neurocognitive Disorder"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to evalute the efficacy of ALZGUARD, a smartphone-based digital therapeutic(DTx), in comparison to diagnosis by medical doctors, as weel as to assess the safety of the application.", "detailedDescription"=>"The study will be conducted across multiple sites, enrolling participants aged 55 to 85 years olds.\n\nThe primary objective of the study is to compare the diagnositic accuracy of ALZGAURD against traditional diagnostic evaluactions conducted by medical professionals. The primary endpoint for efficacy will be the Area Under the Curve(AUC), which will measure the diagnostic performance of the application. This statistical metric will help determine how well ALZGUARD can identify dementia compared to standard diagnostic methods."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"55 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Participants must be between 55 and 85 years old (both men and women).\n* Participants must be able to understand and voluntarily agree to the purpose, content, and procedures of the clinical trial.\n\nExclusion Criteria:\n\n* Participants with no literacy or illiteracy.\n* Participants with an intellectual disability.\n* Participants with presenting active psychiatric symptoms.\n* Participants who have difficulty ALZGUARD application\n* Participants who are unable to use a smartphone, unless they can use it with assistant.\n* Participants with a history of suicidal ideation or suicidal complusion in the last 6 months.\n* Other conditions as deemed inappropriate for study participant by the Principal Investigator(PI)."}, "identificationModule"=>{"nctId"=>"NCT06615167", "briefTitle"=>"Confirmatory Clinical Trial for Verifying the Efficacy and Safety of 'ALZGUARD' as a Digital Dementia Diagnostic Aid-Tool for the Diagnosis of the Major Neurocognitive Disorders", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"HAII corp.ltd"}, "officialTitle"=>"A Single-blind (Data Analyst 1), Single-arm Design, Prospective, Multi-center Confirmatory Clinical Trial for Verifying the Efficacy and Safety of 'ALZGUARD' as a Digital Dementia Diagnostic Aid-Tool for the Diagnosis of the Major Neurocognitive Disorders According to DSM-5", "orgStudyIdInfo"=>{"id"=>"G00020"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"ALZGUARD Intervention Group", "description"=>"All participants wil use the ALZGAURD smartphone-based digital therapeutic(DTx) to assess cognitive function for detecting dementia.", "interventionNames"=>["Device: ALZGUARD"]}], "interventions"=>[{"name"=>"ALZGUARD", "type"=>"DEVICE", "description"=>"A digital therapeutic(DTx) application that uses artifical intelligence to analyze cognitive function and provide a diagnosis of dementia.", "armGroupLabels"=>["ALZGUARD Intervention Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Chuncheon", "state"=>"Kangwon", "status"=>"RECRUITING", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"YeShin Kim", "role"=>"CONTACT", "email"=>"yeshins@gmail.com"}, {"name"=>"KungHee Bae", "role"=>"CONTACT", "email"=>"khjy2@naver.com"}, {"name"=>"YeShin Kim", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Kangwon National University Hospital", "geoPoint"=>{"lat"=>37.87472, "lon"=>127.73417}}, {"city"=>"Seoul", "status"=>"RECRUITING", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"GeonHa Kim", "role"=>"CONTACT", "email"=>"geonha@ewha.ac.kr"}, {"name"=>"JiSook Lim", "role"=>"CONTACT", "email"=>"jsskin@naver.com"}, {"name"=>"GeonHa Kim", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Ewha Womans University Mokdong Medical Center", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}, {"city"=>"Seoul", "status"=>"RECRUITING", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"MinYoung Jeon", "role"=>"CONTACT", "email"=>"myc5198@gmail.com"}, {"name"=>"JiSu Jeong", "role"=>"CONTACT", "email"=>"xodud1234@yuhs.ac"}, {"name"=>"MinYoung Jeon", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Yongin Severance Hospital", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}], "centralContacts"=>[{"name"=>"Rachel Lee", "role"=>"CONTACT", "email"=>"rachel.lee@haii.io", "phone"=>"+82 10-7390-5023"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"HAII corp.ltd", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
