Araclon Biotech, a Grifols company dedicated to the research and development of therapies and diagnostic methods to be applied to degenerative diseases, and MedAvante, Inc., the leader in technology-based clinical trial services for central nervous system (CNS) diseases, today announced that Araclon Biotech has selected MedAvante’s groundbreaking Virgil® Investigative Study Platform for its upcoming Phase 2 trial in prodromal or very mild Alzheimer’s disease (AD).
The Araclon study will investigate the safety, tolerability and immune response of ABvac40, a treatment based on an innovative, specific active immunotherapy against the beta-amyloid 40 protein designed to combat Alzheimer’s disease at its initial stage.
MedAvante will provide the Virgil electronic clinical outcome assessment (eCOA) platform for all clinician-rated outcome assessments to maximize outcome data quality and increase operational efficiency. The Virgil platform, consisting of a tablet device for digital capture with access to the industry’s largest library of electronic rating scales translated to dozens of languages and a tightly integrated web portal for real time data analysis, is currently being used in trials at more than 900 sites in 30 countries.
In addition, MedAvante training will help to standardize the multinational rater cohort, and MedAvante clinicians will perform diagnostic verification and Central Review of the key screening assessments to ensure the quality of administration.
“The ability to detect a sufficient signal to demonstrate efficacy in this type of trial is put at risk by several factors, including the complexity of clinical outcome assessment data, the potential to include ineligible subjects or inflate baseline scoring, and the variability among raters with diverse backgrounds collecting the outcome measures,” said Christopher Randolph, PhD, ABPP-CN, Chief Scientific Officer at MedAvante. “For Araclon Biotech, the Virgil platform and MedAvante clinical services address all these risks.”
“Araclon Biotech is very pleased to enlist MedAvante’s clinical experience and technology leadership for our Phase 2 trial to evaluate the efficacy of the ABvac40 compound,” said Manuel Sarasa, Scientific Director of Araclon Biotech. “In the Phase 1 study, the vaccine demonstrated a good safety and tolerability profile and produced an immune response in a high percentage of patients but does not assess its effectiveness as a treatment.”
“Anticipating our next study, we looked at all options and determined MedAvante brings not only the most eCOA experience, but can also offer a high degree of clinical expertise on study team and the ability to scale their services to a trial the size of ours,” he said. “The Virgil eCOA platform will ensure that we collect high quality outcome data and MedAvante’s clinical cohort will help us to be certain that we’re enrolling the right patients and screening them accurately.”
MedAvante pioneered electronic source (eSource) data capture in 2009 for use by its own clinicians and since then has garnered more eSource experience than anyone else in the industry – more than 630,000 assessments and eSource data accepted by both the FDA and the EMA in successful regulatory submissions.
Filed Under: Drug Discovery
