A Study That Uses an Organized System to Prospectively Collect Uniform Data From a Defined Population

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

As the population increases and aging intensifies, cognitive disorders represented by Alzheimer's disease (AD) not only pose a severe threat to public health but also bring significant social and economic burdens. Previously, treatment options for Alzheimer's disease were very limited, mainly providing symptomatic relief with few available medications. Lecanemab, an FDA-approved clinical treatment drug in 2023, targets the core pathology of AD-abnormal amyloid-beta (Aβ) aggregation in the brain-and has been validated through both biomarker and clinical scale assessments. The optimal dosage and safety-efficacy profile of lecanemab for treating early AD have been observed in phase 2 and phase 3 clinical trials. However, the use of lecanemab may lead to certain adverse effects, including infusion-related reactions, amyloid-related imaging abnormalities (ARIA), such as microhemorrhages or hemosiderin deposits (ARIA-H), and ARIA-E. This study aims to establish a prospective follow-up cohort of patients treated with lecanemab to observe changes in cranial imaging characteristics and clinical symptoms, assess the cognitive improvement effects of lecanemab in early AD patients (stages 3-4), and monitor the risk factors for adverse event occurrence.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 85
Healthy Volunteers: f
View:

• Mini-Mental State Examination (MMSE) score between 22 and 30, Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score between 0.5 and 1;

• Confirmation of positive amyloid pathology by Amyloid-PET or cerebrospinal fluid Aβ testing;

• Completion of APOE gene testing.

• Willingness to use Lecanemab.

Locations
Other Locations
China
Affiliated Hospital, School of Medicine, Zhejiang University, China
RECRUITING
Hangzhou
Contact Information
Primary
Yanxing Chen, M.D.
chenyanxing@zju.edu.cn
+86 188 6840 1257
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2027-06
Participants
Target number of participants: 120
Treatments
Treated Group
This is an observational study. The investigators included early AD patients treated with Lecanemab, and evaluated them by plasma, magnetic resonance imaging (MRI) examination and clinical scale. The investigators observed the changes in MRI characteristics and clinical symptoms of patients after Lecanemab administration, evaluated the improvement effect of Lecanemab on cognitive function, and monitored the risk factors of adverse reactions.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov