Thermo Fisher Scientific Inc., has enrolled the first patient in the new PPD CorEvitas Alzheimer’s Disease Registry. Designed as an international, multi-country initiative, the registry is designed to generate robust, harmonized, fit-for-purpose real-world data under a common global protocol to support novel evaluations of drug safety and effectiveness that are critical for regulators, clinicians, patients and caregivers.

Its longitudinal design, coupled with clinician-reported data from routine practice, will generate a comprehensive understanding of Alzheimer’s therapy outcomes in real-world settings. The registry will illuminate long-term safety, treatment patterns and the evolving use of approved therapies, while also helping to identify unmet medical needs, clarify the disease’s impact on patients, and evaluate the clinical outcomes associated with existing treatment options.

Detailed monitoring and assessment of drug safety events are integral to the registry. This includes MRI-based evaluations of brain bleeding and swelling that may occur with certain treatments, as well as measures of plaque clearance, an important measure of treatment effectiveness in correlation with cognition outcomes. This data will help generate a more complete understanding of safety and clinical outcomes in this patient population.

“The launch of this registry reflects the power of collaboration between clinicians, industry partners and scientific leaders to accelerate progress in Alzheimer’s disease research,” said Peter Wahl, Sc.D, vice president and global head of scientific affairs for PPD CorEvitas Clinical Registries, Thermo Fisher Scientific. “Together, we are building a regulatory-grade, real-world evidence foundation that will help shape the understanding of current and next generation of therapies.”