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Home SCIENCE NEWS Social & Behavioral Science

Alzheimer’s Association announces national effort to collect “real world” data on newly-approved treatments

November 9, 2021
in Social & Behavioral Science
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BOSTON and CHICAGO, November 9, 2021 — 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, along with other clinical research experts, today announced a national registry, The National Treatment and Diagnostic Alzheimer’s Registry. This new national registry will be an FDA-approved-agent agnostic approach to gathering routine clinical practice data and outcomes for sharing quickly and transparently with all stakeholders.

Alzheimer's Association logo

Credit: Alzheimer’s Association

BOSTON and CHICAGO, November 9, 2021 — 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, along with other clinical research experts, today announced a national registry, The National Treatment and Diagnostic Alzheimer’s Registry. This new national registry will be an FDA-approved-agent agnostic approach to gathering routine clinical practice data and outcomes for sharing quickly and transparently with all stakeholders.

Earlier this year, the FDA gave accelerated approval for Aduhelm (Biogen/Eisai). This is the first treatment approved to treat patients in the Alzheimer’s disease stage studied in the clinical trials — people with mild cognitive impairment (MCI) or mild dementia stage of disease. The sponsors of at least two other disease-modifying drugs for Alzheimer’s are on record that they are applying to the FDA for accelerated approval. These, along with other experimental treatments in the pipeline, make a national registry essential for researchers, clinicians, and people living with the disease. 

“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,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer. “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 two to three years.”

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 Alzheimer’s,” said Carrillo.

The registry will be designed to continuously collect routine clinical practice data over time from healthcare providers caring for patients diagnosed with Alzheimer’s who are taking an FDA-approved disease-modifying treatment. The registry will be designed to grow with scientific and medical advancements. As new drugs are approved and implemented in care, these will also be captured by the registry. 

“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,” said Carrillo.

The announcement of the National Treatment and Diagnostic Alzheimer’s Registry was made by Carrillo at the Clinical Trials on Alzheimer’s Disease conference (CTAD) in Boston.

“In addition to supporting scientific efforts, this registry will  equip government funding and regulatory agencies with vital information to guide policy, education, approval and grantmaking decisions,” Carrillo said.

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.

“The Alzheimer’s Association is perfectly positioned to lead this effort — and we have the experience, team and infrastructure already in place through registries we’ve built and operated for our IDEAS and New IDEAS studies,” Carrillo said. 

###

About the Alzheimer’s Association®

The Alzheimer’s Association leads the way to end Alzheimer’s and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer’s and all other dementia®. For more information, visit alz.org or call the 24/7 Helpline at 800.272.3900.

 



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