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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard-Dose Treatment Group | lecanemab 10mg/kg |
| |
| Low-Dose Treatment Group | lecanemab 5-10mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lecanemab 10 mg/kg | Drug | Lecanemab 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Aβ-PET centiloid values | Statistical Comparison of Standard-Dose Treatment Group and Low-Dose Treatment Group Based on Aβ-PET Centiloid Scores | Baseline, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 6 months, 12 months, 18 months |
| Change from Baseline in the Mini-Mental State Examination (MMSE) at 18 Months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiong Zhou | Contact | 13958125492 | ze-zj@zju.edu.cn | |
| Yaping Yan | Contact | +86 151 6831 2676 | yanyaping@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Subject Research Ethics Committee, 2ndAffiliated Hospital, School of Medicine, Zhejiang University, | Hangzhou | Zhejiang | China |
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|
| Lecanemab 5-10mg/kg | Drug | Lecanemab Injection Concentrate Solution 5-10mg/kg, the dose based on the actual dosage administered to patients in the real-world setting |
|
Assessment of the Statistically Significant Difference in MMSE Scores Between Standard-Dose Treatment Group and Low-Dose Treatment Group |
| Baseline, 6 months, 12 months, 18 months |
| 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 | Baseline, 6 months, 12 months, 18 months |
| 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 | Baseline, 6 months, 12 months, 18 months |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000612089 | lecanemab |
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