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Table 1 Overview of characteristics of included crenezumab studies

From: Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer’s disease

StudyPhaseDesignTreatmentsSubjects
ABBY [8]IIDouble-blind, placebo-controlled, randomized, parallel-group studyPart 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]IIDouble-blind, placebo-controlled, randomized studyPart 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 [10,11,12]IbDouble-blind, placebo-controlled, randomized study followed by open-label extensionDouble-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
  1. 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