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

Alzheimer's disease (AD) manifests itself in cognitive decline, impaired ability to perform daily life, and a variety of behavioral and psychiatric symptoms, seriously endangering the health of the elderly. The prevalence and disability rates of AD in China remain high, and the lack of effective treatment options has brought a heavy burden to patients and their families. Early intervention is regarded as an effective strategy to improve clinical symptoms, delay disease progression and maintain current quality of life. The humanized monoclonal antibody lencanemab (Lecanemab) was approved by the U.S. FDA in July 2023 for the treatment of mild cognitive impairment or mild dementia caused by AD, and was officially approved in January 2024 in China. Lencanemab highly targets soluble and insoluble neurotoxic β-amyloid (Aβ) proteins, reducing pathogenic Aβ plaque deposition and preventing its formation in the brains of AD patients, thus reducing neurotoxicity and improving patients' cognitive functions. In addition, lencanumab may also play a neuroprotective role by modulating synaptic plasticity and regulating neural network activity in brain neurons. However, there is a lack of clinical studies to prove this mechanism. In this study, we will enroll consecutive patients with early AD treated with lencanemab infusion as well as those receiving conventional anti-dementia therapy, and comprehensively assess the effects and intrinsic molecular mechanisms of lencanemab on synaptic function and neural networks using magnetic resonance imaging, molecular imaging positron emission tomography (PET), neuropsychological assessment, and analysis of blood cerebrospinal fluid samples.

NCT Number	NCT06871839
Lead Sponsor	Cuibai Wei，Clinical Professor Collaborators: Eisai (China) Pharmaceutical Co., Jinan Hospital, Xuanwu Hospital, Capital Medical University, RenJi Hospital, First Hospital of China Medical University, Nanjing Brain Hospital, Guangdong Provincial People's Hospital, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of University of Science and Technology of China, The First Hospital of Chongqing Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, West China Hospital, The First Hospital of Jilin University
Conditions	Alzheimer's Disease, Lecanemab, Functional Magnetic Resonance Imaging
Enrollment	120 participants
Start Date	2025-03-10
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-22