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A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

NCT07170150•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

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

Locations (135)

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

Key Dates

Start Date

November 12, 2025

Primary Completion Date

June 7, 2028

Completion Date

June 7, 2028

Last Updated

March 16, 2026

Enrollment

800

ESTIMATED participants

Conditions

Alzheimers Disease

Interventions

Trontinemab

DRUG

Placebo

OTHER

Contacts

Reference Study ID Number: WN45447 https://forpatients.roche.com/

CONTACT

888-662-6728 global-roche-genentech-trials@gene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001

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A Study to Evaluate Safety and Tolerability of Different Doses and Efficacy of PQ912 in Subjects With MCI and Mild AD