A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
ConditionAlzheimers Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-90
SponsorHoffmann-La Roche
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Trontinemab
- Placebo
Treatment groups
800 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov