Describe baseline characteristics from the Phase III GRADUATE I (NCT03444870) and GRADUATE II (NCT03443973) studies.

Gantenerumab is a fully human anti-amyloid beta (Aβ) monoclonal antibody in development for the treatment of Alzheimer’s disease (AD). Two multicenter, randomized, double-blind, placebo-controlled, Phase III studies, GRADUATE I and II, are ongoing, assessing the efficacy and safety of subcutaneous gantenerumab in early AD.

Eligible participants (50–90 years) had prodromal AD or mild probable AD dementia (i.e., early AD); demonstrated abnormal memory using the Free and Cued Selective Recall Test; met criteria for the Mini-Mental State Examination (MMSE; ≥22) and the Clinical Dementia Rating – Global Score (0.5 or 1); and showed evidence of Aβ pathology confirmed by Aβ positron emission tomography scan or cerebrospinal fluid analysis.  Participants were randomized 1:1 to subcutaneous gantenerumab or placebo, administered at the study site or at home using home nursing. Study drug is titrated over a 9-month period to a target monthly dosage of 1,020 mg, regardless of apolipoprotein E ε4 status. The primary endpoint is the change from baseline to Week 116 in Clinical Dementia Rating scale – Sum of Boxes. Secondary efficacy measures, fluid and imaging biomarkers, and safety are also being assessed.

Recruitment for GRADUATE I and II is complete. Participants were enrolled from 32 countries across 5 different continents: Asia, Australia, Europe, North America, and South America.  Detailed baseline characteristics will be presented.

The GRADUATE trials are investigating the safety and efficacy of gantenerumab (1,020 mg monthly dosage) compared with placebo in participants with early AD for up to 27 months. Using the FCSRT, the population is enriched for participants who are more likely to progress during the study. Subcutaneous administration allows for administration by a healthcare professional at the participant’s home. Eligible participants may enter an OLE following completion of the GRADUATE trials.