Thermo Fisher Scientific Inc., which is regarded as the world leader when it comes to serving science, went on to announce the enrollment of the first patient in the new PPD™ CorEvitas™ Alzheimers Disease Registry. Crafted as an international as well as a multi-country initiative, the registry is bound to generate robust and harmonized as well as fit-for-purpose real-world data under a generic global protocol in order to support the novel assessments of drug safety as well as effectiveness, which are poised to be critical for clinician, regulator, patient, and also caregiver communities.
The longitudinal design that it has, teeming with clinician-reported data that comes from routine practice, is going to generate a comprehensive understanding of the outcomes of Alzheimer’s therapy when it comes to real-world settings. The registry is going to illuminate long-term safety and treatment patterns as well as the evolving usage of therapies that stand approved, while at the same time helping to identify the unmet medical requirements, clarify the impact of the disease on patients, and also assess the clinical outcomes that are associated with the present treatment alternatives.
Alzheimer’s disease is a progressive neurodegenerative disorder that gradually damages the brain cells, thereby impairing memory, language, and decision-making capacities and, at the end of the day, the capacity to go ahead and perform the daily tasks. Almost 7.2 million Americans that are aged 65 and older are living with Alzheimer’s, a number which is indeed anticipated to double by 2050. Being a leading cause of death in the United States, the disease goes on to represent a major public health challenge and also highlights the requirement for rigorous evidence in order to guide the therapeutic development and, along with it, patient care. Although there is at present no way to cure or even prevent Alzheimer’s, treatments may go on to help manage the symptoms and thereby potentially slow decline.
Detailed tracking and evaluation when it comes to drug safety events are quite integral to the registry. This goes on to include the MRI-based assessments of brain bleeding as well as swelling, which may as well occur due to certain treatments and measures pertaining to plaque clearance, which, by the way, is a major measure of treatment effectiveness in terms of correlation along with cognition outcomes. This data is sure going to help generate a much more complete understanding in terms of safety and clinical outcomes within this patient population.
Vice president and global head of scientific affairs when it comes to PPD CorEvitas Clinical Registries for Thermo Fisher Scientific, Peter Wahl, Sc.D., said that the launch of this registry goes on to reflect the power of partnerships between clinicians, the industry partners, and scientific leaders in order to accelerate the progress when it comes to Alzheimer’s disease research. He added that together they are indeed building a regulatory-grade and a real-world evidence foundation, which is going to help shape the understanding of present and next-generation therapies.
With this, the CorEvitas Alzheimers Disease Registry goes on to expand the growing portfolio of PPD™ CorEvitas™ Clinical Registries, which are proprietary disease registries that are full of robust, structured, as well as clinician- and patient-reported data that span over 500 investigator sites and also longitudinal data collected on more than 100,000 patients. These registries, needless to say, go on to play an essential role when it comes to supporting post-authorization safety studies and at the same time have also gotten due recognition from regulators across the globe.
