Clinical trial Recruiting at 1 site Observational Ages Any age to 85

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.

More Alzheimer Disease trials

Quick facts

Study typeObservational
AgesAny age to 85 Years
SexAll
Enrollment120 (estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Academic / other
Drugs / interventionsLecanemab
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedJune 28, 2024
Main results expectedJune 2026
Study endsJune 2027
Registry record updatedSeptember 3, 2025
Trial IDNCT06741553 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.