Could an antibody stop Alzheimer's before it starts?
NCT ID NCT07717411
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,600 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2032
An estimate. End dates often move.
- Lead sponsor
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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
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55 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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