This study will analyze the clinical indicators, imaging data, and serum biomarkers of Alzheimer's disease (AD) patients receiving different doses of the medication before and after treatment. It aims to clarify whether the therapeutic efficacy in the low-dose group is equivalent to that in the recommended-dose group, and meanwhile to determine the optimal dose range for effective pharmacotherapy.
Meet the diagnostic criteria for AD-derived MCI or early AD [Clinical rating: CDR 0.5 (MCI) / 1.0 (mild AD), i.e., clinical stage 3-5; PIB-PET positive for pathology]
Male or female
50-85 years old
Not currently participating in other research studies
Other neurological disorders: e.g., vascular dementia, dementia with Lewy bodies, frontotemporal lobar degeneration, prion diseases, etc.
Systemic diseases or metabolic disorders: e.g., hypothyroidism, vitamin B12 deficiency, hepatic and renal failure.
Infectious diseases: e.g., neurosyphilis, HIV-associated encephalopathy, and other infectious diseases.
Psychiatric disorders: cognitive symptoms caused by severe depression (pseudodementia), schizophrenia, etc.
This study included early AD patients treated with Standard-Dose Lecanemab (10mg/kg) and Low-Dose Lecanemab (5-10mg/kg) at the Second Affiliated Hospital of Zhejiang University School of Medicine.
Case-control
Cross-sectional
Lecanemab 10 mg/kg
DrugLecanemab Injection Concentrate Solution (active ingredient at 100 mg/mL) is provided as a sterile aqueous solution containing 100 mg/mL of Lecanemab, 50 mmol/L citric acid, 350 mmol/L arginine/arginine hydrochloride, and 0.05% (w/v) polysorbate 80, with a pH of 5.0, and each vial is capable of being drawn into a volume of 5 mL.
Lecanemab 5-10mg/kg
DrugLecanemab Injection Concentrate Solution 5-10mg/kg, the dose based on the actual dosage administered to patients in the real-world setting
Aβ-PET centiloid values
Statistical Comparison of Standard-Dose Treatment Group and Low-Dose Treatment Group Based on Aβ-PET Centiloid Scores
Change from Baseline in the Clinical Dementia Rating (CDR) at 18 Months
Assessment of the Statistical Difference in CDR Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group
Change from Baseline in the Mini-Mental State Examination (MMSE) at 18 Months
Assessment of the Statistically Significant Difference in MMSE Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group
Change from Baseline in the Montreal Cognitive Assessment (MoCA) at 18 Months
Assessment of the Statistically Significant Difference in MoCA Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group
Change from Baseline in the Neuropsychiatric Inventory (NPI) at 18 Months
Assessment of the Statistically Significant Difference in NPI Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group
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