Alzheimer’s Association and Partners Announces National Registry

It is an FDA-approved-agent agnostic approach to gathering routine clinical practice data and outcomes for sharing and transparency.

The Alzheimers Association, the American College of Radiology, the American Society of Neuroradiology, the Department of Biostatistics at Brown University, and other clinical research experts have announced the National Treatment and Diagnostic Alzheimer’s Registry.

“Creation of a national provider registry for disease-modifying Alzheimer’s treatments, and for the associated diagnostic tests and biomarkers, is meant to swiftly advance the science,” Maria C. Carrillo, PhD, chief science officer at the Alzheimer’s Association, said in a statement. “The pipeline is growing, and more exciting advances are around the corner, including several more disease-modifying therapies that may be approved in the next 2 to 3 years.”

The national registry will be an FDA-approved-agent agnostic approach to gathering routine clinical practice data and outcomes for sharing and transparency.

It is designed to continuously collect routine clinical practice data overtime from health care providers on individuals diagnosed with Alzheimer disease (AD) who are taking an FDA-approved, disease-modifying treatment and will grow alongside medical and scientific advancements.

New drug approvals and implementations will also be captured by the registry.

The Alzheimers Association will provide funding to launch the project but will then seek additional funding from government and philanthropic sources.

This year, the FDA gave accelerated approval for Aduhelm (Biogen/Eisai), the first treatment approved to treat individuals with AD.

Similar registries in cancer and heart disease help 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 Alzheimer's,” Carrillo said.

Reference

Alzheimer's Association announces national effort to collect "real world" data on newly-approved treatments. EurekAlert. News release. November 9, 2021. Accessed on November 10, 2021. https://www.eurekalert.org/news-releases/934375