This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD.
Body weight of 150 kg or less
Willingness and ability to complete all aspects of the study for the duration of the study
Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
Cognitively and functionally unimpaired as defined by the protocol
Any evidence of a condition other than AD that may affect cognition, including, but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson disease, corticobasal syndrome, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal lobar degeneration (other than frontotemporal dementia), Huntington disease, normal pressure hydrocephalus, seizure disorder, delirium, or hypoxia
Mild cognitive impairment (MCI; may be referred to as prodromal AD), or any form of dementia
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
Parallel
Trontinemab
DrugParticipants will receive IV trontinemab.
Placebo
DrugParticipants will receive IV placebo.
Time to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0
Change from Baseline through Week 216 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Change from Baseline through Week 216 in Free and Cued Selective Reminding Test (FCSRT) total recall score
Change from Baseline through Week 216 in Digit Symbol Substitution Test (DSST) coding score
Change from Baseline through Week 216 in Cognitive Function Instrument (CFI) study partner, total score
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