Alzheimer DiseasePhase 4ECL-LecanemabNCT07688460
Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers
A Phase 4 study testing Lecanemab in people with Alzheimer Disease, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Lecanemab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 30 Mar 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease).
- History of brain hemorrhage, microbleeds, or superficial siderosis on MRI.
- Use of anticoagulants that cannot be safely interrupted.
- Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study.
- Known hypersensitivity to Lecanemab or any excipients.
- Pregnant or breastfeeding women.
- Participation in another interventional clinical trial within the last 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Xuhua Xu, +86 13705790560, fupinglangying@zju.edu.cn
About this study
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
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.
Read the detailed description
Background:
Lecanemab is an antibody used for the treatment of Alzheimer's disease (AD). Monitoring its therapeutic efficacy accurately is crucial for patient management. Traditional methods can be complex or less sensitive. This study introduces a highly sensitive electrochemiluminescence (ECL) assay using mesoporous gold electrodes to detect AD-related plasma biomarkers.
Study Design:
This is an observational/clinical study involving patients diagnosed with Alzheimer's disease who are receiving Lecanemab treatment.
Methodology:
Blood samples will be collected from participants at scheduled visits. The levels of specific AD biomarkers in the plasma will be measured using the developed mesoporous gold electrode ECL system. These measurements will be correlated with clinical outcomes to assess the drug's efficacy. The study also aims to establish the reliability and sensitivity of this specific ECL technique for routine clinical monitoring.
- Conditions
- Alzheimer Disease
- Being tested
- Lecanemab
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LecanemabDrug
Participants will receive Lecanemab (10 mg/kg) via intravenous infusion every two weeks for a total of 18 months. The dosage and frequency follow the standard prescribing information for Alzheimer's disease treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Lecanemab Treatment Group | Experimental | 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. Receives: Drug: Lecanemab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Alzheimer's Biomarkers
The concentration of specific biomarkers (e.g., Aβ42, p-Tau181) in plasma will be measured using the mesoporous gold electrode ECL system. The change from baseline to the end of treatment will be calculated to evaluate therapeutic efficacy.
Measured: Baseline and every 4 weeks during the 18-month treatment period
Secondary outcomes (1)
Change in CDR-SB Score
Cognitive function will be assessed using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Scores range from 0 to 18, with higher scores indicating greater impairment. Change from baseline will be analyzed.
Measured: Baseline, Month 6, Month 12, and Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label study designed to evaluate the efficacy of Lecanemab in treating Alzheimer's disease and to validate a novel ECL-based monitoring system. All participants will receive the standard Lecanemab treatment regimen.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688460
- Sponsor's protocol ID
- KY-2026-002
- Acronym
- ECL-Lecanemab
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07688460
- Acronym / sponsor ID
- ECL-Lecanemab / KY-2026-002
- Conditions
- Alzheimer Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Lecanemab is an antibody used for the treatment of Alzheimer's disease (AD). Monitoring its therapeutic efficacy accurately is crucial for patient management. Traditional methods can be complex or less sensitive. This study introduces a highly sensitive electrochemiluminescence (ECL) assay using mesoporous gold electrodes to detect AD-related plasma biomarkers.
Study Design:
This is an observational/clinical study involving patients diagnosed with Alzheimer's disease who are receiving Lecanemab treatment.
Methodology:
Blood samples will be collected from participants at scheduled visits. The levels of specific AD biomarkers in the plasma will be measured using the developed mesoporous gold electrode ECL system. These measurements will be correlated with clinical outcomes to assess the drug's efficacy. The study also aims to establish the reliability and sensitivity of this specific ECL technique for routine clinical monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label study designed to evaluate the efficacy of Lecanemab in treating Alzheimer's disease and to validate a novel ECL-based monitoring system. All participants will receive the standard Lecanemab treatment regimen.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Lecanemab Treatment Group | Experimental | Drug: LecanemabParticipants 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease).
- History of brain hemorrhage, microbleeds, or superficial siderosis on MRI.
- Use of anticoagulants that cannot be safely interrupted.
- Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study.
- Known hypersensitivity to Lecanemab or any excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LecanemabParticipants will receive Lecanemab (10 mg/kg) via intravenous infusion every two weeks for a total of 18 months. The dosage and frequency follow the standard prescribing information for Alzheimer's disease treatment. | Drug | Experimental: Lecanemab Treatment Group |
Primary outcome
Change in Plasma Alzheimer's Biomarkers
Time frame: Baseline and every 4 weeks during the 18-month treatment period
The concentration of specific biomarkers (e.g., Aβ42, p-Tau181) in plasma will be measured using the mesoporous gold electrode ECL system. The change from baseline to the end of treatment will be calculated to evaluate therapeutic efficacy.
1 secondary outcome
Change in CDR-SB Score
Time frame: Baseline, Month 6, Month 12, and Month 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lecanemab in people with Alzheimer Disease, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuhua Xu (+8613705790560, fupinglangying@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Alzheimer's Biomarkers (time frame: Baseline and every 4 weeks during the 18-month treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.