The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease

RecruitingOBSERVATIONAL
Enrollment

120

Participants

Timeline

Start Date

March 10, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Alzheimer's DiseaseLecanemabFunctional Magnetic Resonance Imaging
Interventions
DRUG

Lecanemab treatment group

"Lecanemab treatment group: 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. Lecanemab is to be administered via intravenous infusion over 60 minutes in saline solution. Lecanemab must be administered using an infusion system that includes a terminal 0.22 μM inline filter. The dosage of Lecanemab is 10 mg/kg.~All subjects in the Lecanemab treatment group receive Lecanemab infusion therapy at a frequency of once every two weeks for a continuous period of 12 months."

DRUG

Conventional anti-dementia treatment group

Conventional anti-dementia treatment: Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment.

Trial Locations (1)

Unknown

RECRUITING

Capital Medical University Xuanwu Hospital, Beijing

Sponsors
All Listed Sponsors
collaborator

Eisai (China) Pharmaceutical Co.

UNKNOWN

collaborator

Jinan Hospital, Xuanwu Hospital, Capital Medical University

UNKNOWN

collaborator

RenJi Hospital

OTHER

collaborator

First Hospital of China Medical University

OTHER

collaborator

Nanjing Brain Hospital

UNKNOWN

collaborator

Guangdong Provincial People's Hospital

OTHER

collaborator

Zhejiang University

OTHER

collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

collaborator

The First Affiliated Hospital of University of Science and Technology of China

OTHER

collaborator

The First Hospital of Chongqing Medical University

UNKNOWN

collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

collaborator

West China Hospital

OTHER

collaborator

The First Hospital of Jilin University

OTHER

lead

Cuibai Wei,Clinical Professor

OTHER