Observational study of early Alzheimer's patients treated with Lecanemab
Official title: A Study That Uses an Organized System to Prospectively Collect Uniform Data From a Defined Population
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT06741553 · Data updated 2026-11-12
This study is testing if the drug Lecanemab is safe and effective for people with early Alzheimer's disease and mild cognitive impairment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 85 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | Lecanemab |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | June 28, 2024 |
| Main results expected | June 2026 |
| Study ends | June 2027 |
| Registry record updated | September 3, 2025 |
| Trial ID | NCT06741553 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with early Alzheimer's disease or mild cognitive impairment, confirmed by specific cognitive assessments and amyloid pathology testing.
✕Probably not a fit
Patients with significant hemorrhagic conditions, those unable to tolerate MRI scans, or those on anticoagulants may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study follows a cohort of patients diagnosed with early Alzheimer's disease and mild cognitive impairment who are treated with Lecanemab, a drug that targets amyloid-beta aggregation in the brain. The study aims to assess the safety and efficacy of Lecanemab, which has shown promise in previous clinical trials. Participants will undergo evaluations to confirm amyloid pathology and will be monitored for potential adverse effects related to the treatment. The goal is to gather data that could inform future treatment protocols for Alzheimer's disease.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of Lecanemab in slowing cognitive decline in early Alzheimer's patients.
How similar studies have gone: Previous studies have shown success with Lecanemab in treating Alzheimer's, indicating a promising approach to managing the disease.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Yanxing Chen, M.D.
- Email: chenyanxing@zju.edu.cn
- Phone: +86 188 6840 1257
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.