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New drug aims to slow Alzheimer's in chinese patients

NCT ID NCT07571161

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 7 times

Summary

This study tests donanemab, an experimental drug, against a placebo in 140 Chinese adults who show early signs of Alzheimer's risk. Participants receive the drug intravenously every few weeks for up to 3 years. The goal is to see if donanemab can delay memory loss and help maintain daily living skills.

What this could mean

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

Active substance
donanemab
What this could lead to
If it works, this could slow memory and function decline in early Alzheimer's, offering a new treatment option for Chinese patients.
What could go wrong
This is a Phase 3 trial, but results from other populations have been mixed. The drug may not work or could cause side effects like brain swelling.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

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

Started

Apr 2026

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

55 to 80 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: * A Telephone Interview for Cognitive Status - Modified (TICS-M) score indicative of intact cognitive function (cut-off score of 35 or higher) * Clinical Dementia Rating-Global Score (CDR-GS) of 0 * A plasma P-tau result consistent with amyloid pathology * A reliable study partner who: * Provides written informed consent to participate in the study in their role * Has frequent contact with the participant and is familiar with their overall function and behavior, including daily activities and cognitive abilities * Is of legal age (18 years of age or older) to consent * Is available to conduct functional scales * Have adequate literacy, vision, and hearing for neuropsychological testing Exclusion Criteria: * Have mild cognitive impairment (MCI), dementia, or other significant neurodegenerative diseases that could affect cognition * Have a serious or unstable illness (including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease, or other condition) that, in the investigator's opinion, could interfere with study analyses or result in a life expectancy of 5 years or fewer * Have received active or passive immunization against amyloid beta (Aβ) in any other study * Have current or prior use of prescription medications for treatment of MCI or AD * Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or other accessory medical devices, such as cardiac pacemakers, stents, and cochlear implants * Have a centrally read magnetic resonance imaging (MRI) demonstrating the presence of Amyloid-related imaging abnormalities (ARIA-E), more than 4 cerebral microhemorrhages, more than 1 area of cortical superficial siderosis, any macrohemorrhage (that is, intracerebral hemorrhage more than 1 cm), or severe white matter disease at screening

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    30 sites. 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

  • 2nd Affiliated Hospital Chongqing Medical University

    RECRUITING

    Chongqing, 400010, China

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, 230036, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, 350001, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, China

  • Huashan Hospital, Fudan University

    RECRUITING

    Shanghai, 201107, China

  • Jiangsu Province Official Hospital

    RECRUITING

    Nanjing, 210008, China

  • Jinan Central Hospital

    RECRUITING

    Jinan, 250100, China

  • Nanjing Brain Hospital

    RECRUITING

    Nanjing, 210029, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, 100191, China

  • Pudong New Area People's Hospital Shanghai

    RECRUITING

    Shanghai, 201200, China

  • Qinghai Provincial People's Hospital

    RECRUITING

    Xining, 810007, China

  • Renji Hospital Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, 200127, China

  • Shaanxi provincial people's hospital

    RECRUITING

    Xi'an, 710068, China

  • Shanghai East Hospital

    RECRUITING

    Shanghai, 200120, China

  • Shanghai Sixth People's Hospital

    RECRUITING

    Shanghai, 200030, China

  • ShenZhen People's Hospital

    RECRUITING

    Shenzhen, 518020, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, 610072, China

  • Sir Run Run Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, 211166, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, 400016, China

  • The First Affiliated Hospital of Nanyang Medical College

    RECRUITING

    Nanyang, 473061, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, 325027, China

  • The First Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, 050031, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, 100012, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, 330038, China

  • The Second Hospital of Jiaxing

    RECRUITING

    Jiaxing, 314000, China

  • Tianjin Medical University General Hospital

    RECRUITING

    Tianjin, 300052, China

  • Xiangya Hospital Central South University

    RECRUITING

    Changsha, 410008, China

  • Xianyang Hospital of Yan'an University

    RECRUITING

    Xianyang, 712000, China

  • Zigong First People's Hospital

    RECRUITING

    Zigong, 643000, China

  • Zunyi First People's Hospital

    RECRUITING

    Zunyi, 563002, China

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