National Treatment and Diagnostic Alzheimer Disease Registry Announced
Launch of a new national registry to collect real-world evidence on the diagnosis, treatment, and outcomes in Alzheimer disease (AD) has been announce. The registry is a joint initiative of The Alzheimer’s Association; the American College of Radiology; the American Society of Neuroradiology: and the Department of Biostatistics, Brown University School of Public Health, and other clinical research experts.
The registry will gather data from clinical practices in a treatment-agnostic approach, gathering routine clinical practice data and outcomes for people taking any disease-modifying treatment approved by the Food and Drug Administration (FDA). A key aim of the registry is to quickly and transparently share data with all stakeholders. The registry will be designed to grow with scientific and medical advancements and will add new treatments as they are approved and implemented in care.
The registry was announced at the Clinical Trials on Alzheimer Disease meeting in Boston, MA, November 9-12 during a panel discussion on the recent, controversial decision by the Food and Drug Administration (FDA) to approve aducanumab (Aduhelm, Biogen, Cambridge, MA and Eisai, Woodcliff Lake, NJ) via the accelerated approval pathway. Panelist Dr. Maria C. Carillo, PhD, chief science officer of the Alzheimer's Association, made the announcement and emphasized access to treatment and information is essential to take advantage of the progress being made in AD.
Aducanumab is the first treatment approved to treat people with mild cognitive impairment (MCI) or mild dementia stage of AS. Other disease-modifying drugs for AD, lecanemab and donanumab are expected to be submitted to the FDA for approval via the accelerated pathway in the coming months. These, along with other experimental treatments in the pipeline, make a national registry essential for researchers, clinicians, and people living with the disease.
Dr. Carillo also noted that similar successful registries in heart disease and cancer have enabled stakeholders to track the long-term performance of therapies using a large, real-world evidence dataset. “There is an urgent unmet need to provide effective treatments for all who need them, and a transparent approach that allows for immediate sharing of data will not only accelerate advances, but identify gaps in effectiveness and safety, and highlight opportunities to improve care and treatment for all affected by AD,” said Carrillo.
“We need to assess the benefits that people from all backgrounds and communities derive from this and future treatments in the real world—in other words, outside of narrowly constrained clinical trials. We also need to push for additional, even more effective therapies. This initiative aims to achieve this goal,”
The Alzheimer’s Association will provide the initial seed funding to launch the project. The Association will then seek additional funding from government and philanthropic sources.