054 Baseline characteristics of the Phase III GRADUATE studies: investigating subcu- taneous gantenerumab in early AD. Issue 9 (12th August 2022)

• Record Type: Journal Article
• Authors: Lane, Christopher; Bullain, Szofia; Thanasopoulou, Angeliki; Delmar, Paul; Boada, Mercè; Grim-Mer, Timo; Kerwin, Diana; Baudler-Klein, Monika; Kerchner, Geoffrey A; Doody, Rachelle S
• Is Part Of: Journal of neurology, neurosurgery and psychiatry. Volume 93:Issue 9(2022)
• Page Start: e2
• Publication Date: 2022-08-12
• Subjects: Neurology -- Periodicals; Nervous system -- Surgery -- Periodicals; Psychiatry -- Periodicals; 616.8
• DOI: 10.1136/jnnp-2022-abn2.98
• Languages: English
• ISSNs: 0022-3050

Abstract

Abstract : Gantenerumab is a fully human anti-amyloid beta (Aβ) monoclonal immunoglobulin G1 antibody in devel- opment for the treatment of Alzheimer's disease (AD). Two ongoing multicentre, randomised, double-blind, placebo-controlled, Phase III studies, GRADUATE I (NCT03444870 ) and GRADUATE II (NCT03443973 ), are assessing the efficacy and safety of subcutaneous gantenerumab in early AD for 27 months. Eligible participants had prodromal AD or probable AD dementia; demonstrated abnormal memory using the Free and Cued Selective Recall Test; met criteria for the Mini-Mental State Examination (≥22) and Clinical Dementia Rating – Global Score (0.5-1); and had confirmed Aβ pathology. Participants were randomised 1:1 to receive subcutaneous gantenerumab or placebo, administered at study site or via home nursing. The study drug is titrated in three up-titration steps (120 mg, 225 mg, 510 mg monthly) over 9-months to the target 1, 020 mg monthly dosage. All participants receive the same titration and target dose, regardless of apolipoprotein E β4 status. The GRADUATE primary endpoint is 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 is complete. Participants were enrolled from 32 countries across 5 continents. Detailed baseline characteristics will be presented.