A Study 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

NCT07169578

Run by

Hoffmann-La Roche

People needed

800

Starts

2025-09-17

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

• Banner Sun Health Research Institute — Sun City, Arizona, United States (enrolling)
• Irvine Center for Clinical Research — Irvine, California, United States (enrolling)
• Inglewood Clinicals — Los Angeles, California, United States (enrolling)
• UCSF - Memory and Aging Center — San Francisco, California, United States (enrolling)
• Syrentis Clinical Research — Santa Ana, California, United States (enrolling)
• K2 Medical Research - The Villages — Lady Lake, Florida, United States (enrolling)
• K2 Medical Research, LLC — Maitland, Florida, United States (enrolling)
• Renstar Medical Research — Ocala, Florida, United States (enrolling)
• Axiom Brain Health LLC — Tampa, Florida, United States (enrolling)
• Charter Research - Lady Lake/The Villages — The Villages, Florida, United States (enrolling)
• Alzheimer?s Research and Treatment Center — Wellington, Florida, United States (enrolling)
• Conquest Research, LLC — Winter Park, Florida, United States (enrolling)
• Alzheimer's Research and Treatment Center - Columbus — Columbus, Georgia, United States (enrolling)
• Accel Research Sites-NeuroStudies — Decatur, Georgia, United States (enrolling)
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States (enrolling)
• RE:Cognition (Chicago) — Chicago, Illinois, United States (enrolling)
• Tandem Clinical Research, LLC — Marrero, Louisiana, United States (enrolling)
• Brigham and Womens Hospital — Boston, Massachusetts, United States (enrolling)
• Boston Center for Memory — Newton, Massachusetts, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• The Cognitive and Research Center of New Jersey — Ridgewood, New Jersey, United States (enrolling)
• Basil Clinical — Laurelton, New York, United States (enrolling)
• Weill Cornell Medical College — New York, New York, United States (enrolling)
• Adams Clinical Harlem — New York, New York, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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