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New study aims to pinpoint which Alzheimer's patients respond best to antibody drug

NCT ID NCT07152418

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study will test the antibody drug lecanemab in 120 people with mild cognitive impairment or mild-to-moderate Alzheimer's disease. Using PET scans to measure amyloid and tau proteins in the brain, researchers hope to identify which patients are most likely to benefit from treatment. The study also looks at whether continuing lecanemab helps people whose disease progresses to moderate dementia.

What this could mean

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

Active substance
Lecanemab (a monoclonal antibody given by IV infusion)
What this could lead to
If successful, this could help identify which Alzheimer's patients are most likely to benefit from lecanemab and whether continuing treatment slows decline even in moderate stages.
What could go wrong
This is an early-stage study with only 120 participants, so results may not apply to everyone. Some patients may not respond, and the treatment requires regular IV infusions with potential side effects.

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.

Participants

About 120 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2028

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.

Who is studied

This study included early AD patients treated with Lecanemab and Conventional Anti-Dementia Treatment at the Second Affiliated Hospital of Zhejiang University School of Medicine.

Ages

50 to 85 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: * Meet the diagnostic criteria for Mild Cognitive Impairment (MCI) due to Alzheimer's Disease or mild-to-moderate AD. \[Clinical Scores: CDR Global Score = 0.5 (for MCI) or 1 (for mild AD), corresponding to clinical stages 3-4, with a positive PIB-PET scan confirming amyloid pathology\] * Male or Female * Between 50 and 85 years old (inclusive) * Not currently participating in any other clinical trial or research study * Participants must provide informed consent for this trial prior to enrollment and must voluntarily sign a written informed consent form * Participants must be able to communicate effectively with the investigator and are expected to comply with the study requirements to completion Exclusion Criteria: * Any contraindication to MRI * History of seizure within the past 6 months or refractory epilepsy. * Unstable or severe psychiatric illness within the past 6 months. * History of bleeding disorders, coagulopathy, or clinically significant coagulation abnormalities (e.g., platelet count \<50,000/μL or INR \>1.5). * Uncontrolled diabetes mellitus or hypertension. * History of unstable angina, myocardial infarction, advanced heart failure, or clinically significant conduction abnormalities within the past year. * Active cancer treatment (e.g., chemotherapy, biologics, or radiation therapy), except maintenance therapy for cancers in remission (e.g., anti-estrogen therapy for breast cancer). * Immunological disorders requiring ongoing immunosuppression, immunoglobulin therapy, monoclonal antibodies, or plasmapheresis. * Breastfeeding individuals or women of childbearing potential not using highly effective contraception. * History of severe allergic, anaphylactic reactions, or hypersensitivity to any inactive ingredients.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

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

Alzheimer dementia Alzheimer disease (AD) Mild cognitive impairment (MCI)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.