Baseline participant characteristics of GRADUATION: a study to evaluate once‐weekly subcutaneous administration of gantenerumab

Gantenerumab, a human monoclonal antibody targeting aggregated beta‐amyloid (Abeta), is a potential disease‐modifying treatment for early (prodromal‐to‐mild) Alzheimer’s disease (AD). Exposure‐dependent signals of clinical efficacy were observed with low‐dose gantenerumab in post hoc analyses of the SCarlet RoAD study (NCT01224106) in participants with prodromal AD.1 Open‐label extension studies with uptitration to doses of up to 1,200 mg every 4 weeks (q4w) confirmed substantial Abeta removal without new or unexpected safety findings.2 Two Phase III studies are ongoing to assess efficacy and safety of subcutaneous gantenerumab in early AD, using a target dose of 510 mg q2w (GRADUATE I/GRADUATE II [NCT03444870/NCT03443973]). The GRADUATION trial (NCT04592341) will evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of once‐weekly (q1w) administration of gantenerumab (255 mg) in participants with early (prodromal‐to‐mild) AD. Subcutaneous q1w administration of gantenerumab may simplify home dosing to meet the individual needs and preferences of people with AD and their caregivers, and to improve their experience by providing additional flexibility and convenience.