Blood Test to Track How Lecanemab Works in Alzheimer's Disease
Uses a new blood test to follow lecanemab treatment in people with Alzheimer's disease.
Key facts
- Who runs it
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Where
- Yiwu, ChinaSee the site
- Trial code
- Registry title
- Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 100 people, planned
- Started
- 10 Jul 2026
- Expected to end
- 30 Mar 2029
- Type of study
- Interventional
- Treatments tested
- Lecanemab
- Record updated
- 7 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with mild cognitive impairment or mild dementia due to Alzheimer's disease, with confirmed amyloid in the brain, who will be treated with Lecanemab.
- Age
- 50 to 90 years (inclusive)
- Sex
- All sexes can join.
- Disease stage
- Mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia; MMSE score between 22 and 30; CDR global score of 0.5 or 1.
- Earlier treatment
- Stable dose of allowed other medicines for at least 4 weeks before screening.
- Biomarker or test result
- Confirmed amyloid pathology: positive amyloid PET scan or CSF biomarkers.
Main reasons for not taking part
- Other significant brain or nerve diseases, such as stroke or Parkinson's disease
- History of brain hemorrhage, microbleeds, or superficial siderosis on MRI
- Use of anticoagulants that cannot be safely interrupted
- Severe body-wide illness, such as severe heart failure or uncontrolled diabetes
- Known allergy to Lecanemab or its other ingredients
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia
- Age between 50 and 90 years (inclusive)
- Confirmed presence of amyloid pathology (positive amyloid PET scan or CSF biomarkers)
- Mini-Mental State Examination (MMSE) score between 22 and 30
- Clinical Dementia Rating (CDR) global score of 0.5 or 1
- Stable dose of allowed concomitant medications for at least 4 weeks prior to screening
- Willing and able to comply with the study procedures, including blood draws for ECL monitoring
- Signed informed consent form
Who cannot take part
- Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease)
- History of brain hemorrhage, microbleeds, or superficial siderosis on MRI
- Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study
- Known hypersensitivity to Lecanemab or any excipients
- Use of anticoagulants that cannot be safely interrupted
- Pregnant or breastfeeding women
- Participation in another interventional clinical trial within the last 30 days
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 90 years old?
Where in China
- The First Affiliated Hospital, Zhejiang University School of MedicineYiwu, ChinaContact: Xuhua XuTaking people
About the trial
What the trial wants to find out
This study aims to evaluate the therapeutic efficacy of Lecanemab in patients with Alzheimer's disease. The researchers will use a novel detection method based on mesoporous gold electrode surface-enhanced electrochemiluminescence (ECL) to monitor specific biomarkers in the patients' plasma. By tracking changes in these biomarkers, the study seeks to determine how effectively Lecanemab treats the disease and to validate this new ECL-based monitoring system as a useful tool for clinical assessment.
The group in the trial
- Experimental: Lecanemab Treatment GroupTreatment being tested
Participants in this arm will receive Lecanemab treatment according to the standard clinical protocol for Alzheimer's disease. Their plasma biomarkers will be monitored using the mesoporous gold electrode ECL system to evaluate therapeutic efficacy.
Treatment: Lecanemab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Construction of a Lecanemab Therapeutic Efficacy Evaluation System Based on Mesoporous Gold Electrode Surface-enhanced Electrochemiluminescence for Monitoring Dynamic Changes of Alzheimer's Disease Plasma Biomarkers
- Plain-language title
- Blood Test to Track How Lecanemab Works in Alzheimer's DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07688460, who can take part
- Record updated
- 7 July 2026