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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Alzheimers Disease

In brief

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).

Key facts

Study ID

NCT07170150

Run by

Hoffmann-La Roche

People needed

800

Starts

2025-11-12

Expected to finish

2028-06-07

Last updated by the study team

2026-08-06

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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