Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)

A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (NCT07170150) is a Phase 3 interventional studying Alzheimers Disease, sponsored by Hoffmann-La Roche. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Alzheimers Disease, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 800 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner - Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted) - Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available - Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4 - Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0 - Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening - A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order - Availability of a "study partner" as defined by the protocol Who Should NOT Join This Trial: - Any evidence of a condition other than AD that may affect cognition - 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 - MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner * Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted) * Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available * Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4 * Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0 * Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening * A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order * Availability of a "study partner" as defined by the protocol Exclusion Criteria: * Any evidence of a condition other than AD that may affect cognition * 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 * MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI * 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 * History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death

Treatments Being Tested

DRUG

Trontinemab

Participants will receive IV trontinemab

OTHER

Placebo

Participants will receive IV placebo

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Banner Alzheimer?s Institute
Phoenix, Arizona, United States
Sun Valley Research Center, Inc.
Imperial, California, United States
Healthy Brain Clinic
Long Beach, California, United States
Oakland Clinical
Oakland, California, United States
Riverside Clinical
Riverside, California, United States
Cenexel California Neuroscience Research, LLC
Sherman Oaks, California, United States
Yale University
New Haven, Connecticut, United States
JEM Research LLC
Atlantis, Florida, United States
K2 Medical Research-Winter Garden
Clermont, Florida, United States
Visionary Investigators Network- Neurology Aventura
Miami, Florida, United States
Charter Research - Winter Park/Orlando
Orlando, Florida, United States
Conquest Research - Lake Nona
Orlando, Florida, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville
Chicago, Illinois, United States
Adams Clinical Watertown
Watertown, Massachusetts, United States
Quest Research Institute
Farmington Hills, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07170150), the sponsor (Hoffmann-La Roche), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07170150 clinical trial studying?

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07170150?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07170150?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07170150. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07170150. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.