NCT07034222 · Phase 4 · ACTIVE NOT RECRUITING
12-Month Real-World Safety & Efficacy of Lecanemab in Early Alzheimer's Disease
Sponsor: Ruijin Hospital
This trial is tracking how well and how safely lecanemab (brand name Leqemi) works in everyday clinical settings over 12 months. Lecanemab is an anti-amyloid antibody already approved for early Alzheimer's disease. Eighty people with MCI or mild AD, confirmed by amyloid PET scan, will be enrolled. This is a Phase 4 study, meaning the drug is already approved and researchers are now watching how it performs in real-world use outside a controlled research setting.
Eligibility criteria
Inclusion Criteria: * Meets the NIA-AA 2011 diagnostic criteria for: Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD) or Mild Alzheimer's Disease Dementia. -Confirmed Aβ pathology by: Aβ-PET scan or CSF Aβ42/Aβ40 ratio (results within 6 months prior to screening). -Cognitive scales (within 3 months): Clinical Dementia Rating (CDR) global score 0.5-1 and/or Mini-Mental State Examination (MMSE) score 20-30. * APOE genotype results available. * MRI/SWI eligibility: * No exclusionary findings (see Exclusion Criteria for details). * Laboratory tests within normal ranges or deemed non-clinically significant by the investigator: Routine tests: Liver/kidney function, CBC, urinalysis, fecal occult blood. Thyroid function: Free T3, free T4, TSH. Vitamin B12 (and methylmalonic acid [MMA], if available). Coagulation panel: PT/INR, aPTT (required). Negative for syphilis, HIV, or other infections that may affect cognition. Exclusion Criteria: - MRI/SWI exclusionary findings: 4 microhemorrhages (maximum diameter ≤10 mm). Any macrohemorrhage (>10 mm in diameter). Cortical superficial siderosis. Vasogenic edema. Evidence of brain contusion, encephalomalacia, vascular malformations, or infectious lesions. Multiple lacunar infarcts/strokes in major vascular territories, severe small vessel disease, or severe white matter lesions (Fazekas grade ≥3). Space-occupying lesions or brain tumors (except asymptomatic meningiomas/arachnoid cysts <1 cm).
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-06-24