Nctid:
NCT06230783
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000544", "term"=>"Alzheimer Disease"}], "ancestors"=>[{"id"=>"D000003704", "term"=>"Dementia"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000024801", "term"=>"Tauopathies"}, {"id"=>"D000019636", "term"=>"Neurodegenerative Diseases"}, {"id"=>"D000019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M3885", "name"=>"Alzheimer Disease", "asFound"=>"Alzheimer's Disease", "relevance"=>"HIGH"}, {"id"=>"M6904", "name"=>"Dementia", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M23002", "name"=>"Tauopathies", "relevance"=>"LOW"}, {"id"=>"M21558", "name"=>"Neurodegenerative Diseases", "relevance"=>"LOW"}, {"id"=>"M21836", "name"=>"Neurocognitive Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"T2192", "name"=>"Familial Alzheimer Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>150}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06", "completionDateStruct"=>{"date"=>"2028-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-06-26", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-06-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2028-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Usability of remote at-home speech collection - objective", "timeFrame"=>"3 years", "description"=>"Usability will be measured objectively through the TalkTracker mobile application by obtaining compliance metrics (number of tasks completed, total number of errors, number of help requests)."}, {"measure"=>"Usability of remote at-home speech collection - objective", "timeFrame"=>"3 years", "description"=>"Usability will be measured objectively through the TalkTracker mobile application by obtaining compliance metric of time to completion."}, {"measure"=>"Feasibility of remote at-home speech collection", "timeFrame"=>"3 years", "description"=>"Feasibility will be measured through numbers of retention, adherence, and accrual."}, {"measure"=>"Feasibility of remote at-home speech collection", "timeFrame"=>"3 years", "description"=>"Feasibility will be measured through sample characteristics, and identification of productive recruitment methods."}, {"measure"=>"Feasibility of remote at-home speech collection", "timeFrame"=>"3 years", "description"=>"Feasibility will be measured through identification of productive recruitment methods."}, {"measure"=>"Usability of remote at-home speech collection - subjective", "timeFrame"=>"3 years", "description"=>"Subjective measurement usability will be assessed through the System Usability Scale (SUS) given to participants after each 8-week completion period. The SUS is a 7 item questionnaire, with a range of 1 to 5 (1 = strongly disagree, 5 = strongly agree). Higher scores on questions 1, 3, 5 and 7 indicate lower usability. Higher scores on questions 2, 4 and 6 indicate higher usability."}], "secondaryOutcomes"=>[{"measure"=>"Correlation between in-clinic speech metrics and remote at-home speech metrics", "timeFrame"=>"3 years", "description"=>"Correlation between in-clinic versus at-home speech samples will be measured by calculating the inter-class correlation and standard error of measurement on speech measures of interest (content information units, semantic relevance, words per minute). Determination of variance between in-person and at-home speech samples will be evaluated by analysis of covariance accounting for age, sex, education, and cognitive status."}, {"measure"=>"Correlations between metrics from remote at-home speech and plasma amyloid-beta (pTau-217)", "timeFrame"=>"3 years", "description"=>"Correlations will be determined using mixed effects models examining change in speech measures over time with plasma amyloid-beta, covarying for age, sex and genetic risk factors"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Wisconsin Alzheimer's Disease Research Center", "Wisconsin Registry for Alzheimer's Prevention"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to validate changes in speech as a measure of cognition in individuals at increased risk of Alzheimer's disease and related dementias (ADRD). This study aims to clarify how speech may be affected by Alzheimer's disease.\n\nParticipants will complete speech collection sessions and a survey at home using an iPad. Participants can expect to be in the study for 3 years.", "detailedDescription"=>"Digital technology, including recorded speech, has the capability of providing a wealth of information about early changes to cognition and communication associated with developing Alzheimer's disease pathology, with the potential for highly accessible, yet low-burden measurement. In this project, researchers will recruit a subset of participants from two longitudinal, observational cohort studies enriched for individuals at risk for or living with Alzheimer's disease to record their speech at home with a mobile device, longitudinally. Our interdisciplinary team will then validate digital markers across all stages of Alzheimer's Disease and Related Dementias (ADRD), including the prodromal phase, and can enhance sensitivity and specificity of speech metrics while contributing valuable information about remote, noninvasive, and accessible assessment and disease monitoring."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"40 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Participants will be enrolled from the WRAP and W-ADRC studies", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Must be enrolled in the Wisconsin Alzheimer\\'s Disease Research Center (W-ADRC) Clinical Core or IMPACT studies, or in the Wisconsin Registry for Alzheimer\\'s Prevention (WRAP)\n* Cognitively unimpaired or have a diagnosis of Mild Cognitive Impairment (MCI)\n* Ages 40-80 years\n* Have provided W-ADRC or WRAP with blood plasma Alzheimer's Disease\n\nExclusion Criteria:\n\n* Not actively enrolled in W-ADRC or WRAP\n* Diagnosis of dementia\n* Impaired capacity or unwilling to consent\n* Have not completed a main W-ADRC/WRAP study visit within approximately 6 months of enrollment\n* Major neurological conditions\n* Speech disorders"}, "identificationModule"=>{"nctId"=>"NCT06230783", "acronym"=>"SPEAK-AD", "briefTitle"=>"Speech Pattern Evaluation and Analysis for Knowledge of AD", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Wisconsin, Madison"}, "officialTitle"=>"Connected Language and Speech Along the Spectrum of ADRD: Digital Assessment and Monitoring", "orgStudyIdInfo"=>{"id"=>"2023-1740"}, "secondaryIdInfos"=>[{"id"=>"1R01AG082052-01", "link"=>"https://reporter.nih.gov/quickSearch/1R01AG082052-01", "type"=>"NIH"}, {"id"=>"A534255", "type"=>"OTHER", "domain"=>"UW- Madison"}, {"id"=>"SMPH/MEDICINE/GER-AD DEV", "type"=>"OTHER", "domain"=>"UW- Madison"}, {"id"=>"Protocol Version 12/15/2023", "type"=>"OTHER", "domain"=>"UW- Madison"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"TalkTracker", "type"=>"OTHER", "description"=>"Participants will be asked to complete the speech collection procedures remotely/at home once per week for 8 weeks. The 8-week period of weekly remote speech collection will take place yearly for a total of 3 years. At the end of each 8-week study period for years 1-3, participants will complete a survey that asks questions about how easy/difficult the application was to use, how frustrated they felt using the application, and other usability questions."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"53705", "city"=>"Madison", "state"=>"Wisconsin", "country"=>"United States", "contacts"=>[{"name"=>"Leah K Sanson-Miles", "role"=>"CONTACT", "email"=>"lsanson@wisc.edu", "phone"=>"608-262-7467"}], "facility"=>"University of Wisconsin", "geoPoint"=>{"lat"=>43.07305, "lon"=>-89.40123}}], "centralContacts"=>[{"name"=>"Leah K Sanson-Miles", "role"=>"CONTACT", "email"=>"lsanson@wisc.edu", "phone"=>"608-262-7497"}], "overallOfficials"=>[{"name"=>"Kimberly D Mueller, PhD, CCC-SLP", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Wisconsin, Madison"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Wisconsin, Madison", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Arizona State University", "class"=>"OTHER"}, {"name"=>"National Institute on Aging (NIA)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
