Trontinemab for early symptomatic Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial enrolls people with early symptomatic Alzheimer's disease who have evidence of amyloid pathology by PET or qualifying CSF and meet cognitive criteria. Participants receive trontinemab or placebo and undergo regular cognitive and functional testing alongside safety monitoring. The protocol requires MRI and biomarker procedures (amyloid PET or CSF) and clinical genotyping at screening and during follow-up. The main goals are to see if trontinemab slows clinical decline and to characterize its safety and biomarker effects in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Banner Alzheimer?s Institute
  Phoenix, Arizona, United States Recruiting
• Sun Valley Research Center, Inc.
  Imperial, California, United States Recruiting
• Healthy Brain Clinic
  Long Beach, California, United States Recruiting
• Oakland Clinical
  Oakland, California, United States Recruiting
• Riverside Clinical
  Riverside, California, United States Recruiting
• Cenexel California Neuroscience Research, LLC
  Sherman Oaks, California, United States Recruiting

+100 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: WN45447 https://forpatients.roche.com/
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.