A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease (PrevenTRON)

September 8, 2026 updated by: Hoffmann-La Roche

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease

This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3B 2S7
        • Recruiting
        • Toronto Memory Program
  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
  • United Kingdom
      • Chertsey, United Kingdom, KT16 9AU
        • Recruiting
        • Surrey and Borders NHS Foundation Trust
  • United States
    • California
      • Irvine, California, United States, 92614
        • Recruiting
        • Irvine Center for Clinical Research
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Syrentis Clinical Research
    • Florida
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research, LLC
    • New York
      • Laurelton, New York, United States, 11413-2016
        • Recruiting
        • Basil Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Trontinemab
Participants will receive intravenous (IV) trontinemab.
Drug: Trontinemab
Participants will receive IV trontinemab.
Placebo Comparator: Placebo
Participants will receive IV placebo.
Drug: Placebo
Participants will receive IV placebo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline through Week 216 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Time Frame: Baseline through Week 216
Baseline through Week 216
Change from Baseline through Week 216 in Free and Cued Selective Reminding Test (FCSRT) total recall score
Time Frame: Baseline through Week 216
Baseline through Week 216
Change from Baseline through Week 216 in Digit Symbol Substitution Test (DSST) coding score
Time Frame: Baseline through Week 216
Baseline through Week 216
Change from Baseline through Week 216 in Cognitive Function Instrument (CFI) study partner, total score
Time Frame: Baseline through Week 216
Baseline through Week 216
Change from Baseline through Week 216 in Category fluency total score
Time Frame: Baseline through Week 216
Baseline through Week 216
Change from Baseline through Week 216 in Mini-Mental State Examination (MMSE) total score
Time Frame: Baseline through Week 216
Baseline through Week 216
Change from Baseline through Week 216 in Wechsler Memory Scale, Logical Memory II Delayed Paragraph Recall (WMS LM II [DR]) score
Time Frame: Baseline through Week 216
Baseline through Week 216
Change from Baseline through Week 216 in Amsterdam Instrumental Activities of Daily Living Questionnaire-Short Version (A-IADL-Q-SV) study partner, total score
Time Frame: Baseline through Week 216
Baseline through Week 216
Change from Baseline through Week 216 in Trail Making Test (TMT)
Time Frame: Baseline through Week 216
Baseline through Week 216
Time to progression to adjudicated mild cognitive impairment (MCI) diagnosis
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Incidence of adverse events
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Frequency of amyloid-related imaging abnormalities-edema/effusion (ARIA-E) and amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H) magnetic resonance imaging (MRI) findings
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Severity of ARIA-E and ARIA-H MRI findings
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Frequency of infusion-related reactions (IRRs)
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Severity of IRRs
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Incidence of anti-drug antibodies (ADAs) to trontinemab
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Change from baseline through Week 216 in brain amyloid load, as measured by amyloid positron emission tomography (PET) scan
Time Frame: Baseline through Week 216
Baseline through Week 216
Change from baseline through Week 216 in blood biomarker phosphorylated tau 217 (pTau217)
Time Frame: Baseline through Week 216
Baseline through Week 216
Change from baseline through Week 216 in blood biomarker glial fibrillar acidic protein (GFAP)
Time Frame: Baseline through Week 216
Baseline through Week 216

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 3, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WN46072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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