Table 1.
Overview of characteristics of included crenezumab studies
Study | Phase | Design | Treatments | Subjects |
---|---|---|---|---|
ABBY [8] | II | Double-blind, placebo-controlled, randomized, parallel-group study |
Part 1: Low-dose 300 mg SC crenezumab q4w Part 2: High-dose 15 mg/kg IV crenezumab q4w Placebo q4w SRI: At least 2 monthly administrations of 15 mg/kg IV crenezumab or placebo |
431 patients with mild-to-moderate AD aged 50–80 years were randomized 2:1 (crenezumab:placebo) - Part 1: 184 patients - Part 2: 241 patients - SRI: 13 patients |
BLAZE [9] | II | Double-blind, placebo-controlled, randomized study |
Part 1: Low-dose 300 mg SC crenezumab q4w Part 2: High-dose 15 mg/kg IV crenezumab q4w Placebo q4w |
91 Aβ-positive patients with mild-to-moderate AD aged 50–80 years were randomized 2:1 (crenezumab:placebo) - Part 1: 39 patients - Part 2: 52 patients |
GN29632 [10–12] | Ib | Double-blind, placebo-controlled, randomized study followed by open-label extension |
Double-blind phase: Cohort 1: 30 or 45 mg/kg IV crenezumab q4w Cohort 2: 60 mg/kg IV crenezumab q4w Cohort 3: 120 mg/kg IV crenezumab q4w Placebo q4w Open-label extension: Cohort 1 and 2 could continue to receive crenezumab at the originally assigned dosea Cohort 3 switched to 60 mg/kg q4w Placebo could cross over to crenezumab at the originally assigned dose and 60 mg/kg if assigned to cohort 1 or 3 |
75 patients with mild-to-moderate AD aged 50–90 years were randomized 5:1 at each of the crenezumab dosing levels, or placebo up to week 13: - Cohort 1: 30 mg/kg: 10 patients 45 mg/kg: 11 patients - Cohort 2: 21 patients - Cohort 3: 19 patients 71 patients entered the open-label extension |
aFollowing a protocol amendment, patients in cohort 1 could increase to 60 mg/kg q4w dose after week 133. Abbreviations: Aβ beta-amyloid, AD Alzheimer’s disease, IV intravenous, q4w every 4 weeks, SC subcutaneous, SRI safety run-in