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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:

• Age between 50 and 90 years.

• Male or female patients.

• Patients with MCI and mild AD.

• MMSE score ≥20, CDR overall score of 0.5 or 1.

• Amyloid-positive confirmed by Amyloid-PET or CSF.

• Have a reliable caregiver to accompany the patient during study visits and supervise the use of study medication during the trial.

• Agree to participate in the study and sign the informed consent form.

Locations
Other Locations
China
Capital Medical University Xuanwu Hospital
RECRUITING
Beijing
Contact Information
Primary
Cui bai Wei
weicb@xwhosp.org
83198319
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 120
Treatments
Lecanemab treatment group
Early-stage Alzheimer's disease patients are given Lecanemab infusion treatment in conjunction with conventional anti-dementia drug therapy.
Conventional anti-dementia treatment
Early-stage Alzheimer's disease (AD) patients commonly take cholinesterase inhibitors such as donepezil for treatment.
Related Therapeutic Areas
Sponsors
Collaborators: The First Affiliated Hospital of University of Science and Technology of China, RenJi Hospital, West China Hospital, First Hospital of China Medical University, Nanjing Brain Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang University, Guangdong Provincial People's Hospital, The First Affiliated Hospital of Anhui Medical University, Eisai (China) Pharmaceutical Co., The First Hospital of Jilin University, Jinan Hospital, Xuanwu Hospital, Capital Medical University, The First Hospital of Chongqing Medical University
Leads: Cuibai Wei,Clinical Professor

This content was sourced from clinicaltrials.gov