Administer Leqemi 10 mg/kg, every two weeks.: Receive 10 mg/kg of Leqembi once every two weeks. Dissolve Leqembi in normal saline and administer it intravenously over 60 minutes. The infusion system must use a 0.2-μM terminal line filter for administration.
Study summary
This is a 12-month, single-arm, real-world study designed to evaluate the efficacy and safety of lecanemab (10 mg/kg administered every two weeks) in patients with early Alzheimer's disease, including mild cognitive impairment (MCI) due to AD or mild AD dementia, confirmed by amyloid-positive Aβ-PET scans. The study will enroll 80 participants, with both retrospective and prospective data collection.
Eligibility
Sex
ALL
Min age
50 Years
Max age
90 Years
Healthy volunteers
No
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).
Primary outcome measure(s)
Change in Amyloid Burden as Assessed by Aβ-PET Standardized Uptake Value Ratio (SUVR) — Baseline, 6 months, 12 months Measurement:
Unit of Measure: SUVR (unitless ratio) Reference Region: Cerebellar gray matter Range: Typically 1.0-3.0 in amyloid-positive subjects Direction: Lower values indicate greater amyloid clearance
Change in Amyloid Burden as Assessed by Centiloid Scale — Baseline, 6 months, 12 months Measurement:
Unit of Measure: Centiloids (CL)
Scale Range:
0 CL: Young healthy controls 100 CL: Typical Alzheimer's dementia threshold Direction: Lower values indicate greater amyloid clearance
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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