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)
Hoffmann-La Roche
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 range
- 50–90 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugTrontinemab
Participants will receive IV trontinemab
- OtherPlacebo
Participants will receive IV placebo
Locations (146)
- Banner Alzheimer?s InstitutePhoenix, Arizona
- Sun Valley Research Center, Inc.Imperial, California
- Healthy Brain ClinicLong Beach, California
- Oakland ClinicalOakland, California
- Riverside ClinicalRiverside, California
- Cenexel California Neuroscience Research, LLCSherman Oaks, California