NCT06741553 Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab
| NCT ID | NCT06741553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-06-28 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Unable to tolerate MRI scans; * MRI showing hemorrhagic manifestations, including \>4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations; * Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding; * With unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding.
Contact & Investigator
Baorong Zhang, M.D.
STUDY DIRECTOR
Zhejiang University School of Medicine Second Affiliated Hospital
Frequently Asked Questions
Who can join the NCT06741553 clinical trial?
This trial is open to participants of all sexes, up to 85 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06741553 currently recruiting?
Yes, NCT06741553 is actively recruiting participants. Contact the research team at chenyanxing@zju.edu.cn for enrollment information.
Where is the NCT06741553 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06741553 clinical trial?
NCT06741553 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Baorong Zhang, M.D. at Zhejiang University School of Medicine Second Affiliated Hospital. The trial plans to enroll 120 participants.
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