NCT07034222 · Phase 4 · ACTIVE NOT RECRUITING
12-Month Real-World Safety & Efficacy of Lecanemab in Early Alzheimer's Disease
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