[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638257":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":57,"locations":63,"responsibleParty":78,"collaborators":37,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":37,"eligibilityCriteria":87,"healthyVolunteers":84,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":37,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":106,"whyStopped":37,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,16,22,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","No digital cognitive training + maximum statin tolerance only Participants receive maximally tolerated statin (rosuvastatin 20mg or atorvastatin 40mg daily, with optional ezetimibe 10mg at investigator discretion) for 24 weeks. No digital cognitive training. Instead, they receive low-difficulty standardized tasks as active control (same tablet, contact time, and push frequency but no adaptive multi-domain training).",[13,14,15],"Drug: Rosuvastatin","Drug: Ezetimibe","Behavioral: Active Control",{"label":17,"type":18,"description":19,"interventionNames":20},"Lipid-lowering intervention group","EXPERIMENTAL","No digital cognitive training + maximum tolerance statin plus PCSK9 inhibitor Participants receive maximally tolerated statin (as in Arm 1) plus subcutaneous PCSK9 inhibitor (Recaticimab) injections: 150mg at week 0, 300mg at week 4, 450mg at week 12. No digital cognitive training; they receive the same low-difficulty active control as in Arm 1. Total treatment duration is 24 weeks.",[13,14,21,15],"Drug: Recaticimab",{"label":23,"type":18,"description":24,"interventionNames":25},"Training intervention group","Digital cognitive training + maximum statin tolerance only Participants receive maximally tolerated statin (as in Arm 1) for 24 weeks. In addition, they undergo 12 weeks of digital cognitive training: adaptive, multi-domain (processing speed, attention, perception, memory, language, executive function) delivered via tablet. Participants are asked to train 30 minutes\u002Fday, 5 days\u002Fweek. Minimum dose: ≥3 days\u002Fweek and ≥20 minutes\u002Fsession or ≥60 minutes\u002Fweek.",[13,14,26],"Behavioral: Digital Cognitive Training",{"label":28,"type":18,"description":29,"interventionNames":30},"Combined intervention group","Digital cognitive training + maximum tolerance statin plus PCSK9 inhibitor Participants receive both intensive interventions: maximally tolerated statin plus PCSK9 inhibitor (Recaticimab injections at weeks 0,4,12 as in Arm 3) \\*\\*and\\*\\* 12 weeks of digital cognitive training (same adaptive program as in Arm 2). Total treatment duration is 24 weeks.",[13,14,21,26],[32,38,42,46,53],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Rosuvastatin","Rosuvastatin 20mg or Atorvastatin 40mg orally once daily, at the maximally tolerated dose, for 24 weeks. Dose may be adjusted for intolerance or safety.",[28,9,17,23],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Ezetimibe","Ezetimibe 10mg orally once daily, at investigator's discretion, in combination with statin therapy for 24 weeks.",[28,9,17,23],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"Recaticimab","Recaticimab (PCSK9 inhibitor) subcutaneous injection: 150mg at week 0, 300mg at week 4, 450mg at week 12, on top of maximally tolerated statin ± ezetimibe. Total treatment duration 24 weeks.",[28,17],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"BEHAVIORAL","Digital Cognitive Training","Tablet-based adaptive cognitive training covering six domains: processing speed, attention, perception, memory, language, and executive function. Participants are instructed to train 30 minutes\u002Fday, 5 days\u002Fweek for 12 weeks. The system adjusts difficulty based on performance.",[28,23],[52],"Computerized Cognitive Training (CCT)",{"type":47,"name":54,"description":55,"armGroupLabels":56,"otherNames":37},"Active Control","Participants receive low-difficulty standardized tasks on the same tablet platform, with similar contact time and push frequency as the intervention group. No adaptive multi-domain training is provided. Used to control for non-specific effects of device use and attention.",[9,17],[58],{"name":59,"role":60,"phone":61,"phoneExt":37,"email":62},"Zijue Wang, MD","CONTACT","+86 15901586608","Zijue_wang@163.com",[64],{"facility":5,"status":37,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Beijing","Beijing Municipality","100730","China","CN",{"type":71,"coordinates":72},"Point",[73,74],116.39723,39.9075,{"lat":74,"lon":73},[77],{"name":59,"role":60,"phone":61,"phoneExt":37,"email":62},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","ZijueWang","Assistant Researcher","100638257","phase-4-efficacy-and-safety-study-of-digital-cognitive-training-and-pcsk9-inhibitor-enhanced-lipid-lowering-strategy-in-patients-with-intracranial-atherosclerotic-stenosis-a-22-randomized-controlled-trial-100638257",false,"NCT07605130","Efficacy and Safety Study of Digital Cognitive Training and PCSK9 Inhibitor-Enhanced Lipid-lowering Strategy in Patients With Intracranial Atherosclerotic Stenosis: A 2×2 Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 55-80 years old\n2. The number of years of education is greater than or equal to 6 years\n3. 50%-99% stenosis of the intracranial artery confirmed by MRA, CTA or DSA\n4. Head CT or MRI confirmed that there were no infarct lesions\u002Fsoftening foci larger than 3 cm in the brain\n5. LDL-C ≥ 1.8mmol\u002FL at baseline\n6. Decline in cognitive function of the complainant\n7. MMSE ≥ 24 points; no severe impairment of daily living and social functioning, and the daily living ability scale (ADL, 14-item BADL and IADL combined version, total score range of 14-56 points) \\\u003C=18; and the investigator's clinical assessment does not meet the diagnosis of dementia (DSM-V or NIA-AA diagnostic criteria)\n8. Proficient in operating electronic products such as mobile phones and tablets\n9. Complete the operation evaluation through the introduction period (see the definition of the introduction period)\n10. Agree to receive maximally tolerated statin and PCSK9 inhibitor therapy during the study period\n11. Able to cooperate with neuropsychological and multimodal magnetic resonance examinations\n\nExclusion Criteria:\n\n1. Extracranial vascular stenosis ≥ 50%\n2. Acute cerebrovascular events within 90 days\n3. Contraindications to MRI (metal implants in the body, claustrophobia, etc.)\n4. Visual and auditory impairments, as well as communication difficulties, that affect cognitive training\n5. Clinically diagnosed vascular dementia\n6. Neuroimaging showing significant white matter lesions (Fazekas grade 3) or multiple microbleeds\n7. Non-atherosclerotic intracranial artery stenosis (such as vasculitis, moyamoya disease, dissection, etc.)\n8. Neurodegenerative diseases (Alzheimer's disease, Parkinson's disease, etc.)\n9. Severe comorbidities (tumors, multiple sclerosis, severe cardiopulmonary and renal diseases, intracranial aneurysms)\n10. Other diseases that may affect cognition have been ruled out; severe anxiety, depression, or schizophrenia; a new stroke occurring within the 3 months prior to baseline; hereditary or inflammatory small vessel diseases; presence of any of the following clear sources of cardioembolic events: mitral stenosis, mechanical heart valves, endocarditis, intracardiac clots or vegetations, dilated cardiomyopathy, chronic or paroxysmal atrial fibrillation, ejection fraction less than 30%\n11. Planning to use medications that may affect cognitive function within the past 3 months or in the following 24 weeks, including large amounts of sedatives, anti-anxiety drugs, cognitive enhancers, and cholinergic agents.(12) Previously treated with a PCSK9 inhibitor\n12. Having a clear contraindication or severe intolerance to PCSK9 inhibitors or statins (such as a history of severe allergic reactions)\n13. Presence of significant liver or muscle safety abnormalities at baseline, or the investigator deems the patient unsuitable for intensive lipid-lowering therapy (for example, significantly elevated ALT or AST, significantly elevated CK, etc.; the thresholds can be based on the reference ranges of each center's laboratory and specified in the protocol in advance)\n14. Other circumstances deemed inappropriate for enrollment by the investigator","ALL","55 Years","80 Years",{"count":92,"type":93},420,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","This study aims to evaluate whether digital cognitive training and\u002For intensive lipid-lowering therapy with a PCSK9 inhibitor can improve cognitive function in patients with intracranial atherosclerosis (ICAS).\n\nICAS is a common cause of stroke and is also linked to thinking and memory problems. The study will enroll 420 adults aged 55-80 years who have 50-99% narrowing of an intracranial artery, subjective memory complaints, and LDL cholesterol ≥1.8 mmol\u002FL, but who are not demented.\n\nParticipants will be randomly assigned to one of four groups in a 2×2 factorial design:\n\n1. No cognitive training + standard statin therapy\n2. Cognitive training + standard statin therapy\n3. No cognitive training + intensive statin plus PCSK9 inhibitor\n4. Cognitive training + intensive statin plus PCSK9 inhibitor\n\nCognitive training consists of 30 minutes of tablet-based exercises, 5 days per week for 12 weeks. The intensive lipid-lowering group receives a PCSK9 inhibitor (Recaticimab) injection at weeks 0, 4, and 12, on top of maximally tolerated statin.\n\nThe main outcome is change in a composite cognitive score from baseline to 24 weeks. Secondary outcomes include changes in specific cognitive domains, MRI markers of brain structure and function, and safety measures.\n\nThe study is multicenter, open-label with blinded outcome assessment, and is conducted under the approval of the ethics committee of Peking Union Medical College Hospital.",[99,100],"Intracranial Arteriosclerosis","Cognitive Impairment",[102,103,104,105],"Cognitive Dysfunction","Cognitive Training","Artificial Intelligence","Computerised Cognitive Training","NOT_YET_RECRUITING","2026-05-17",{"date":109,"type":110},"2026-05-22","ACTUAL",{"date":112,"type":93},"2026-05-25",{"date":114,"type":93},"2029-07-31",{"name":5,"class":6},1]