Thermo Fisher Scientific Inc. announced the enrollment of the first patient in the new PPD CorEvitas Alzheimer's Disease Registry. Designed as an international, multi-country initiative, the registry will 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 regulator, clinician, patient and caregiver communities. 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 eliminate 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. Alzheimer's disease is a progressive neurodegenerative disorder that gradually damages brain cells, impairing memory, language, decision-making abilities and ultimately, the ability to perform daily tasks. An estimated 7.2 million Americans age 65 and older are living with Alzheimer's1, a number expected to double by 20502.
As a leading cause of death in the United States2, the disease represents a significant public health challenge and underscores the need for rigorous evidence to guide therapeutic development and patient care. Although there is currently no way to prevent or cure Alzheimer's, treatments may help manage symptoms and potentially slow decline. 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. This CorEvitas Alzheimer's Disease Registry expands the growing portfolio of PPD CorEvita Clinical Registries, which are proprietary disease registries containing robust, structured, clinician- and patient-reported data spanning more than 500 investigator sites and longitudinal data collected on over 100,000 patients.
These registries play an essential role in supporting post-authorization safety studies and have been recognized by regulators around the globe.
