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- W2897939079 abstract "Crenezumab is a humanized anti-amyloid-beta (Aβ) monoclonal IgG4 antibody in development for Alzheimer's disease (AD). Crenezumab binds to multiple forms of Aβ, with high affinity for oligomers, blocking oligomer-induced neurotoxicity, and with low risk of amyloid-related imaging abnormalities (ARIA). Although Phase 2 co-primary endpoints were not met, exploratory analyses suggested that crenezumab should be tested for clinically meaningful efficacy at a higher dose and earlier disease stage. Data from a Phase 1b study that investigated the safety/tolerability of higher doses of crenezumab supported a 4-fold higher Phase 3 dose than used in Phase 2. Two global, randomized, double-blind, placebo-controlled, parallel-group Phase 3 studies (CREAD [NCT02670083]; CREAD2 [NCT03114657]) are testing the efficacy and safety of crenezumab (60 mg/kg) in patients with prodromal to mild AD. Here we describe the study design/methodology, and baseline characteristics from CREAD. Patients aged 50–85 years with prodromal to mild AD and confirmed evidence of cerebral amyloid pathology (CSF or amyloid PET) were enrolled. At screening, patients had an MMSE score of ≥22, a CDR-global score of 0.5 or 1, Free and Cued Selective Reminding Test (FCSRT) immediate free recall ≤27 and cueing index ≤0.67 (to enrich for patients with greater likelihood of progression over 105 weeks), and were randomized 1:1 to placebo or crenezumab (60 mg/kg q4w IV). Randomization was stratified by dementia and APOE status, baseline anti-dementia medications, and geographic region. Primary and secondary endpoints include change from baseline in CDR-SB, ADAS-Cog-13, and ADCS-ADL scores over 105 weeks. Exploratory objectives are to assess treatment effects on CSF biomarkers and amyloid- and tau-PET. MRI examinations are used to monitor safety and measure volumetric changes. The CREAD study has completed recruitment, with 813 patients enrolled. Baseline data will be presented. Building on learnings from Phase 2, the CREAD and CREAD2 Phase 3 trials are investigating the clinical efficacy of a 4-fold higher dose of crenezumab (vs. Phase 2) in prodromal to mild AD, and will test whether clinically meaningful efficacy can be achieved without the associated safety findings that have been described with other passive anti-amyloid immunotherapies targeting fibrillar amyloid in AD." @default.
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- W2897939079 date "2018-07-01" @default.
- W2897939079 modified "2023-10-16" @default.
- W2897939079 title "O1‐02‐04: BASELINE CHARACTERICS FROM A PHASE 3 TRIAL OF CRENEZUMAB IN PRODROMAL TO MILD ALZHEIMER'S DISEASE (CREAD)" @default.
- W2897939079 doi "https://doi.org/10.1016/j.jalz.2018.06.2339" @default.
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