An Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer’s Disease (MCI to Mild Dementia Due to AD)

Prior treatment

• Any previous or current use of passive immunotherapy (immunoglobulin) or other long-acting biologic agent that is approved or under evaluation or has been evaluated to prevent or postpone cognitive decline

Other illness

• Any evidence of a condition other than AD that may affect cognition
• 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 or presence of clinically significant cerebrovascular disease
• History of hypersensitivity to biologic agents or any of the excipients in the formulation.

Other

• Inability to tolerate MRI procedures or contraindication to MRI

• Fluency in the language of the tests used at the study site
• Adequate visual and auditory acuity, in the investigator’s judgment, sufficient to perform the neuropsychological testing
• Evidence of AD pathological process as confirmed by amyloid positron emission tomography (PET) scan or CSF
• Screening Mini-Mental State Examination (MMSE) score ≥ 22 and Clinical Dementia Rating, Global Score (CDR-GS) of 0.5 or 1.0
• A Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Delayed Memory Index (DMI) score of 85 or lower
• Availability of an appropriate study partner