[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642364":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":41,"locations":51,"responsibleParty":70,"collaborators":23,"id":73,"slug":23,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":23,"enrollmentInfo":82,"targetDuration":23,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":109,"whyStopped":23,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SCD Participants","EXPERIMENTAL","All 300 SCD participants undergo baseline multimodal assessment. Those found to be AD plasma biomarker positive (SCD+) undergo longitudinal follow-up at M12 and M24. Those classified as high risk (plasma p-tau217 greater than 0.1325 pg\u002FmL, and\u002For APOE epsilon4 carrier, and\u002For elevated CAIDE Dementia Risk Score) additionally receive a 6-month multidisciplinary personalized intervention combining high-frequency TMS, digital cognitive training, structured physical exercise, and targeted vascular and behavioral risk factor management.",[13,14,15,16],"Device: High-frequency Transcranial Magnetic Stimulation (TMS)","Behavioral: Digital Cognitive Training","Behavioral: Structured Physical Exercise","Other: Management of Modifiable Vascular and Behavioral Risk Factors",[18,24,29,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","High-frequency Transcranial Magnetic Stimulation (TMS)","High-frequency repetitive TMS (rTMS) delivered according to an intensive protocol during the first 4 weeks of the intervention period (2-3 sessions per week). Applied to brain regions associated with cognitive function to optimize brain health and reduce risk of cognitive decline. Administered by trained professionals following international safety guidelines (Rossi et al., 2009).",[9],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"BEHAVIORAL","Digital Cognitive Training","Home-based cognitive training delivered via digital platform over 5 months: 2 sessions per week of 30 minutes each. Targets perceived cognitive deficits and related domains (memory, executive functions, attention, visuospatial abilities, language) with progressive adaptation to individual performance level. Compliance monitored via dedicated applications and\u002For activity diaries. Monthly remote meetings with neuropsychologists to monitor progress.",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"Structured Physical Exercise","Home-based structured physical exercise program over 5 months: 2 sessions per week of 30 minutes each. Activities include walking, cycling, and global resistance training. An in-person familiarization session is conducted before program start. Monthly remote meetings with physiotherapists to monitor progress and adapt the program. Compliance remotely monitored via dedicated applications and\u002For activity diaries.",[9],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"Management of Modifiable Vascular and Behavioral Risk Factors","Personalized pharmacological and non-pharmacological interventions targeting modifiable vascular and behavioral risk factors including blood pressure, cholesterol, BMI, physical inactivity, dietary habits, sleep quality, and social isolation. Monthly remote follow-up visits over 6 months to monitor treatment adherence and optimize risk factor control.",[9],[38],{"name":39,"affiliation":5,"role":40},"Massimo Filippi, Prof","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},"Federica FA Agosta, MD","CONTACT","0226433051","agosta.federica@hsr.it",{"name":48,"role":44,"phone":49,"phoneExt":23,"email":50},"Elisa EC Canu, PhD","0226433033","canu.elisa@hsr.it",[52],{"facility":53,"status":23,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"San Raffaele Neurology Unit","Milan","Milano","20132","Italy","IT",{"type":60,"coordinates":61},"Point",[62,63],12.59836,42.78235,{"lat":63,"lon":62},[66,68,69],{"name":67,"role":44,"phone":45,"phoneExt":23,"email":46},"Federica Agosta, MD",{"name":48,"role":44,"phone":49,"phoneExt":23,"email":50},{"name":39,"role":40,"phone":23,"phoneExt":23,"email":23},{"type":40,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Prof. Massimo Filippi","Prof, MD","100642364",false,"NCT07652931","Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory Concerns","AHEAD: AI-driven Brain Health for Early Alzheimer's Disease Detection in Individuals With Subjective Cognitive Decline","AHEAD","Inclusion Criteria:\n\n1. Diagnosis of Subjective Cognitive Decline (SCD) according to international diagnostic criteria (Jessen et al., 2014).\n2. Self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event.\n3. Normal age-, gender-, and education-adjusted performance on standardized cognitive tests used to classify mild cognitive impairment (MCI) or prodromal AD.\n4. Age greater than or equal to 40 years.\n5. Native Italian Speaker.\n6. Stable pharmacological treatment for at least 4 weeks prior to enrollment.\n7. Provision of oral and written informed consent to study participation.\n\nExclusion Criteria:\n\n1. Presence of MCI, prodromal AD, or dementia.\n2. Any major systemic, psychiatric, or neurological disturbance.\n3. Medical conditions or substance abuse that could interfere with cognition.\n4. Pacemaker and\u002For other implanted neurostimulation devices in the head\u002Fneck district.\n5. Contraindications to undergoing MRI examination.\n6. Brain damage at routine MRI, including extensive cerebrovascular disorders.\n7. Traumatic or surgical wounds that could determine a risk of infection at the site of non-invasive stimulation.\n8. Scalp alterations that could determine the spread of excessive current from the device.\n9. Known history of epilepsy (due to small risk of seizure induction from rTMS in epileptic patients).\n10. Denial of oral and written informed consent to study participation.","ALL","40 Years",{"count":83,"type":84},300,"ESTIMATED","INTERVENTIONAL",[87],"NA","AHEAD is a prospective, longitudinal, risk-stratified single-arm interventional study enrolling 300 patients with Subjective Cognitive Decline (SCD) at IRCCS San Raffaele Hospital, Milan, Italy.\n\nThe study uses artificial intelligence (AI) to integrate multimodal data - including MRI, EEG, Optical Coherence Tomography (OCT), neuropsychological assessments, and plasma biomarkers - to identify individuals with underlying Alzheimer's disease (AD) biology and predict cognitive progression.\n\nOnly participants found to be AD plasma biomarker positive (SCD+) undergo longitudinal follow-up at 12 and 24 months. Participants classified as high risk additionally receive a 6-month personalized multidisciplinary intervention combining high-frequency transcranial magnetic stimulation (TMS), digital cognitive training, structured physical exercise, and targeted management of modifiable vascular and behavioral risk factors.",[90,91,92,93],"Subjective Cognitive Decline","Alzheimer Disease","Mild Cognitive Impairment","Cognitive Decline",[90,95,96,97,98,99,100,101,102,103,104,105,106,107,108],"Alzheimer's disease","Artificial Intelligence","Transcranial Magnetic Stimulation","Plasma biomarkers","p-tau217","MRI","EEG","Optical Coherence Tomography","Cognitive Training","Physical Exercise","Brain Health","APOE","Machine Learning","Deep Learning","NOT_YET_RECRUITING","2026-06-11",{"date":112,"type":113},"2026-06-17","ACTUAL",{"date":115,"type":84},"2026-08-01",{"date":117,"type":84},"2029-08-01",{"name":5,"class":6},1]