Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer Dementia; Alzheimer Disease (AD); MCI-AD, Early Stage Alzheimer's Disease
• Intervention / Treatment: Drug: Lecanemab 10 mg/kg; Drug: Lecanemab 5-10mg/kg

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Yaping Yan; Phone Number: +86 151 6831 2676; Email: yanyaping@zju.edu.cn
• Study Contact Backup: Name: Jiong Zhou; Phone Number: 13958125492; Email: ze-zj@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Human Subject Research Ethics Committee, 2ndAffiliated Hospital, School of Medicine, Zhejiang University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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
• Volunteers must provide written informed consent prior to study participation and voluntarily sign the informed consent form
• Volunteers are able to communicate effectively with investigators and comply with study procedures to complete the study

Exclusion Criteria:

• 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.
• Effects of drugs/toxins: long-term use of benzodiazepines, anticholinergic drugs, or alcohol dependence.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard-Dose Treatment Group; lecanemab 10mg/kg	Drug: Lecanemab 10 mg/kg; 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.
Low-Dose Treatment Group; lecanemab 5-10mg/kg	Drug: Lecanemab 5-10mg/kg; Lecanemab Injection Concentrate Solution 5-10mg/kg, the dose based on the actual dosage administered to patients in the real-world setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; lecanemab; different doses
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; lecanemab
• Other Study ID Numbers: 2025-1393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No