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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

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 [10,11,12]

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

  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