12-Month Real-World Safety & Efficacy of Lecanemab in Early Alzheimer's Disease

NCT ID: NCT07034222

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-01-01

Brief 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.

Detailed Description

The study enrolled participants with mild cognitive impairment due to AD or mild AD. All participants received biweekly intravenous infusions of lecanemab at a dose of 10 mg/kg. Safety data was collected, particularly for amyloid-related imaging abnormalities (ARIA). Effectiveness evaluations included cognitive tests, plasma biomarker analysis, and advanced neuroimaging.

Conditions

Alzheimer's Disease(AD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lecanemab treatment group

receive 10 mg/kg of Leqembi once every two weeks. Dissolve Leqembi in normal saline and administer it intravenously over 60 minutes.

Group Type: EXPERIMENTAL

Administer Leqemi 10 mg/kg, every two weeks.

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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:

Exclusion Criteria

• 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.

• 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).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

WENYAN KANG

Professor and Chief Physician, Department of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

References

Kang W, Gao C, Li X, Wang X, Zhong H, Wei Q, Tang Y, Huang P, Shen R, Chen L, Zhang J, Fang R, Wei W, Zhang F, Zhou G, Yuan W, Chen X, Yang Z, Wu Y, Xu W, Zhu S, Zhang L, He N, Fang W, Zhang M, Zhang Y, Ju H, Bai Y, Liu J. Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study. Chin Med J (Engl). 2025 Oct 10. doi: 10.1097/CM9.0000000000003888. Online ahead of print.

Reference Type: DERIVED

PMID: 41069006 (View on PubMed)

Other Identifiers

2025025

Identifier Type: -

Identifier Source: org_study_id