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New blood test could track Alzheimer's treatment in real time

NCT ID NCT07688460

Disease control Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This phase 4 trial tests lecanemab, an antibody treatment for Alzheimer's disease, in 100 people with mild cognitive impairment or mild Alzheimer's dementia. Participants receive lecanemab infusions every two weeks for 18 months. The study also evaluates a new blood test that uses a special gold electrode to measure Alzheimer's-related proteins, aiming to see if it can reliably track how well the treatment works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lecanemab
What this could lead to
If successful, this study could show that lecanemab slows cognitive decline in early Alzheimer's and validate a new blood test to monitor treatment response.
What could go wrong
This is a single-arm, open-label study with no placebo group, so results may be less reliable. Lecanemab can cause brain swelling or bleeding, and the new blood test is still experimental.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia. 2. Age between 50 and 90 years (inclusive). 3. Confirmed presence of amyloid pathology (positive amyloid PET scan or CSF biomarkers). 4. Mini-Mental State Examination (MMSE) score between 22 and 30. 5. Clinical Dementia Rating (CDR) global score of 0.5 or 1. 6. Stable dose of allowed concomitant medications for at least 4 weeks prior to screening. 7. Willing and able to comply with the study procedures, including blood draws for ECL monitoring. 8. Signed informed consent form. Exclusion Criteria: 1. Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease). 2. History of brain hemorrhage, microbleeds, or superficial siderosis on MRI. 3. Use of anticoagulants that cannot be safely interrupted. 4. Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study. 5. Known hypersensitivity to Lecanemab or any excipients. 6. Pregnant or breastfeeding women. 7. Participation in another interventional clinical trial within the last 30 days.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Yiwu, Zhejiang, 322000, China

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