Alzheimer’s Association Announces National Data Registry for Fast and Transparent Data Sharing

November 16, 2021

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The Alzheimer’s Association and collaborators announced the creation of a national database, the National Alzheimer’s Disease Treatment and Diagnosis Registry, at the Alzheimer’s Disease Clinical Trials Conference.

The association, along with the American College of Radiology, the American Society of Neuroradiology, the Department of Biostatistics at the Brown University School of Public Health, and other clinical research experts formed the database as a FDA-approved agent agnostic approach to gathering routine clinical data. practice of data and results for rapid and transparent dissemination to all stakeholders.

Earlier this year, the FDA granted fast-track approval for Aduhelm (aducanumab, Biogen / Eisai), an antibody directed against beta-amyloid. It is the first treatment approved for patients with Alzheimer’s disease who have mild cognitive impairment or a mild stage of dementia.

Sponsors of at least two other disease-modifying drugs for AD have indicated that they will apply for expedited approval to the FDA.

Maria C. Carrillo

“The creation of a national registry of providers for modifying treatments for Alzheimer’s disease, as well as for diagnostic tests and associated biomarkers, aims to rapidly advance science” Married C. Carrillo, PhD, said the scientific director of the Alzheimer’s Association in a press release. “The pipeline is growing and more exciting advancements are around the corner, including several other disease-modifying therapies that may be approved within the next 2-3 years.”

Stakeholders reported previously successful registries in heart disease and cancer research that tracked the long-term performance of certain therapies using a large body of real-world evidence.

“There is an urgent unmet need to deliver effective treatments to all who need them, and a transparent approach that enables immediate data sharing will not only accelerate progress, but identify gaps in efficacy and safety. , and highlight opportunities to improve care and treatment for all affected by Alzheimer’s disease, ”Carrillo continued.

The registry will be designed to continuously collect clinical practice data from healthcare providers caring for patients diagnosed with AD and undergoing FDA-approved disease-modifying therapy. It may also expand depending on the size and scope of scientific and medical advances. When new drugs to treat the disease are approved and implemented in care, they will also be registered in the registry, the statement said.

“We need to assess the benefits that people of all walks of life and communities derive from this treatment and those to come in the real world – in other words, outside of narrowly limited clinical trials,” Carrillo added. “We also need to push for more, even more effective therapies. This initiative aims to achieve this goal.

In addition to supporting scientific efforts, the registry will provide government funding and regulatory agencies with vital information to guide policy, education, approval, and grant-making decisions.

The Alzheimer’s Association is expected to provide seed funding to get the project started, and then later seek additional funding from various government and philanthropic sources.


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