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Could an antibody stop Alzheimer's before it starts?

NCT ID NCT07717411

Prevention Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Last updated Oct 14, 2026 · Updated 5 times

Summary

This study tests whether the experimental drug trontinemab can prevent or delay memory loss and dementia in people who have early biological signs of Alzheimer's but no cognitive symptoms. Participants receive either trontinemab or a placebo intravenously for several years. The goal is to see if the drug can keep them from progressing to mild cognitive impairment or dementia.

What this could mean

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

Active substance
an experimental antibody drug called trontinemab
What this could lead to
If successful, this could lead to the first treatment that delays or prevents the onset of Alzheimer's symptoms in high-risk individuals.
What could go wrong
This is an early-stage prevention trial, so the drug may not slow progression or could cause side effects like brain swelling. Results will take years.

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 1,600 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Sep 2032

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: * Body weight of 150 kg or less * Willingness and ability to complete all aspects of the study for the duration of the study * Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted) * Cognitively and functionally unimpaired as defined by the protocol * Availability of a study partner as defined by the protocol * A plasma pTau217 level consistent with a high likelihood of future clinical progression Exclusion Criteria: * Any evidence of a condition other than AD that may affect cognition, including, but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson disease, corticobasal syndrome, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal lobar degeneration (other than frontotemporal dementia), Huntington disease, normal pressure hydrocephalus, seizure disorder, delirium, or hypoxia * Mild cognitive impairment (MCI; may be referred to as prodromal AD), or any form of dementia * History or presence of clinically significant cerebrovascular disease * History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma * History or presence of clinically significant intracranial mass * History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder * History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 12 months of an acute event that is consistent, in the opinion of the PI, with a transient ischemic attack * At risk for suicide in the opinion of the investigator * Substance abuse disorder within 12 months prior to screening (nicotine use is allowed) * Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments * Uncontrolled hypertension * Impaired hepatic function * History or presence of any clinically significant hematological diseases * Diagnosis of a wet age-related macular degeneration (AMD) * Abnormal thyroid function * Abnormally low serum levels of folic acid or vitamin B12 deficiency that are judged to be clinically significant and/or may impact cognition as per the investigator's judgment * Current HIV, hepatitis B, or hepatitis C infection that has not been adequately treated in the opinion of the investigator * History of malignancy * Any previous administration of active immunotherapy (vaccine) that is being evaluated to prevent or postpone cognitive decline * Any previous or current use of passive immunotherapy (immunoglobulin) or other long-acting biologic agent that is approved or under evaluation or has been evaluated to prevent or postpone cognitive decline * Any other investigational treatment within 5 half-lives or 4 months prior to screening, whichever is longer * Intravenous (IV) or subcutaneous immunoglobulin therapy within 5 half-lives or 4 months prior to baseline whichever is longer * Anticoagulation medications at screening and there should be no plans to initiate any prior to or after randomization * Any treatment with cholinesterase inhibitors * Antipsychotic or neuroleptic medications within 3 months of screening, except as brief treatment for a non-psychiatric indication * Individuals with chronic use of opiates or opioids, benzodiazepines, barbiturates, or hypnotics, antidepressants or medication to treat anxiety should be on a stable dose for at least 8 weeks before baseline * Currently enrolled in an interventional study including those requiring investigational medicinal product (IMP) or involving any type of medical research that may interfere with study cognitive assessments * Residence in a skilled nursing facility such as a convalescent home or long-term care facility

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Conditions

The condition(s) this trial relates to.

Alzheimer disease prevention target

As listed by the trial registrant

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

Alzheimer S disease

How to take part

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

  1. The places running it

    34 sites in 7 countries. 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

  • Basil Clinical

    RECRUITING

    Laurelton, New York, 11413-2016, United States

  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science

    RECRUITING

    Beijing, 100050, China

  • Charing Cross Hospital

    RECRUITING

    London, W6 8RF, United Kingdom

  • Charter Research - Lady Lake/The Villages

    RECRUITING

    The Villages, Florida, 32162, United States

  • Charter Research - Winter Park/Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Conquest Research - Lake Nona

    RECRUITING

    Orlando, Florida, 32832, United States

  • Conquest Research, LLC

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Healthy Brain Clinic

    RECRUITING

    Long Beach, California, 90804, United States

  • Hospital Italiano de Buenos Aires

    RECRUITING

    Buenos Aires, C1181ACH, Argentina

  • Irvine Center for Clinical Research

    RECRUITING

    Irvine, California, 92614, United States

  • K2 Medical Research, LLC

    RECRUITING

    Maitland, Florida, 32751, United States

  • KaRa Institute of Neurological Diseases

    RECRUITING

    Macquarie Park, New South Wales, 2113, Australia

  • Kelowna Health and Memory Centre Ltd.

    RECRUITING

    Kelowna, British Columbia, V1Y 5A8, Canada

  • Moorgreen Hospital

    RECRUITING

    Southampton, SO30 3JB, United Kingdom

  • Nanjing First Hospital

    RECRUITING

    Nanjing, 210029, China

  • Oakland Clinical

    RECRUITING

    Oakland, California, 94609, United States

  • Re:Cognition Health Birmingham

    RECRUITING

    Birmingham, B16 8QQ, United Kingdom

  • Re:Cognition Health London

    RECRUITING

    London, W1G 8TB, United Kingdom

  • Renstar Medical Research

    RECRUITING

    Ocala, Florida, 34470, United States

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Sana Research, LLC

    RECRUITING

    Arlington, Virginia, 22205, United States

  • Scottish Brain Sciences

    RECRUITING

    Aberdeen, AB25 2XE, United Kingdom

  • Scottish Brain Sciences

    RECRUITING

    Edinburgh, EH12 5PJ, United Kingdom

  • Sir Run Run Shaw Hospital Zhejiang University

    RECRUITING

    Hangzhou, 310016, China

  • Surrey and Borders NHS Foundation Trust

    RECRUITING

    Chertsey, KT16 9AU, United Kingdom

  • Syrentis Clinical Research

    RECRUITING

    Santa Ana, California, 92705, United States

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

  • The First Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050031, China

  • The Second Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, 210003, China

  • The Second Affiliated Hospital of Suzhou University

    RECRUITING

    Suzhou, 215025, China

  • The second Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510260, China

  • Toronto Memory Program

    RECRUITING

    Toronto, Ontario, M3B 2S7, Canada

  • Xuanwu Hospital, Capital Medical University

    RECRUITING

    Beijing, 100053, China

  • Yan'an University Xianyang Hospital

    RECRUITING

    Xianyang, Shaanxi, 712000, China

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