Clinical Research Directory
Browse clinical research sites, groups, and studies.
Efficacy and Safety Study of Digital Cognitive Training and PCSK9 Inhibitor-Enhanced Lipid-lowering Strategy in Patients With Intracranial Atherosclerotic Stenosis: A 2x2 Factorial, Randomized, Parallel-Group, Multicenter Trial
Sponsor: Peking Union Medical College Hospital
Summary
This study aims to evaluate whether digital cognitive training and/or PCSK9 inhibitor-enhanced lipid-lowering therapy on top of moderate-intensity statin can improve cognitive function in patients with intracranial atherosclerosis (ICAS). ICAS is a common cause of stroke and is also linked to thinking and memory problems. The study will enroll 440 adults aged 55-80 years who have 50-99% narrowing of an intracranial artery, subjective memory complaints, and LDL cholesterol ≥1.8 mmol/L, but who are not demented. Participants will be randomly assigned to one of four groups in a 2×2 factorial, parallel-group design: No cognitive training + moderate-intensity statin therapy Cognitive training + moderate-intensity statin therapy No cognitive training + moderate-intensity statin plus PCSK9 inhibitor Cognitive training + moderate-intensity statin plus PCSK9 inhibitor Cognitive training consists of 30 minutes of tablet-based exercises, 5 days per week for 24 weeks (first 12 weeks as the intensive phase, followed by 12 weeks continuation phase). The PCSK9 inhibitor (Recaticimab) is administered subcutaneously according to the product label, on top of moderate-intensity statin. The main outcome is change in a composite cognitive score from baseline to 24 weeks. Secondary outcomes include changes in specific cognitive domains, serum LDL-C, MRI markers of brain structure and function, and safety measures. The 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.
Key Details
Gender
All
Age Range
55 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2026-09-17
Completion Date
2029-07-31
Last Updated
2026-09-15
Healthy Volunteers
No
Interventions
Rosuvastatin
Rosuvastatin 10mg or Atorvastatin 20mg orally once daily, at the moderate-intensity dose, for 24 weeks. Dose may be adjusted for intolerance or safety.
Ezetimibe
Ezetimibe 10mg orally once daily, at investigator's discretion, in combination with statin therapy for 24 weeks.
Recaticimab
Recaticimab (PCSK9 inhibitor) subcutaneous injection according to the product label, on top of moderate-intensity statin ± ezetimibe. Total treatment duration 24 weeks.
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/day, 5 days/week for 24 weeks (first 12 weeks as the intensive phase, followed by 12 weeks continuation phase). The system adjusts difficulty based on performance.
Active Control
Participants receive science popularization and health education push notifications. Used to control for non-specific effects of study participation and attention.
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China