First data collection and sharing network for new FDA-approved Alzheimer’s treatments

ALZ-NET is the first network developed specifically for new FDA-approved Alzheimer’s disease treatments, collecting hard evidence on drug efficacy and side effects over a long period of time.

The announcement was made today at the Alzheimer’s Association International Conference® (AAIC®) 2022 in San Diego and virtually. ALZ-NET partner organizations include the American College of Radiology, the Critical Path Institute, the Department of Biostatistics at Brown University School of Public Health, and the American Society of Neuroradiology, as well as other clinical research experts and in imagery.

The goal of ALZ-NET is to improve patient care and outcomes, and to inform Alzheimer’s disease treatment practices, including helping us to better understand and address disparities in health, tracking how people from all walks of life and communities are responding to new FDA-approved Alzheimer’s therapies.

A national system for collecting and sharing drug safety and effectiveness is essential as the landscape for treating Alzheimer’s disease changed dramatically with the accelerated FDA approval of aducanumab in June. 2021, with many late-stage clinical trials expected to be published over the next 12 months.

We are entering a new phase in the treatment of Alzheimer’s disease. ALZ-NET is the tool that will help us translate therapies into care that provides the most benefit to people living with the disease and their caregivers, in all communities. Together with partners and scientific leaders, we seek to develop the future of treatment and diagnosis of Alzheimer’s disease and dementia.”

Maria C. Carrillo, Ph.D., Scientific Director of the Alzheimer’s Association and ALZ-NET Co-Principal Investigator

Similar successful networks for heart disease, cancer, HIV/AIDS and multiple sclerosis have enabled stakeholders to track the long-term performance of therapies.

“ALZ-NET will be a long-term investment for the Alzheimer’s Association. This is a great example of our commitment to improving clinical care and preparedness, and supporting the discovery of innovative drugs,” said Carrillo. “It is imperative that we all work together as a clinical and research community to build this infrastructure because it creates opportunities for evidence gathering, information sharing and education.”

What will ALZ-NET gather and what will it produce?

“ALZ-NET will bring together real-world clinical practice data and outcomes, including treatment efficacy and side effects,” said Gil D. Rabinovici, MD, co-principal investigator of ALZ-NET and Edward Fein and Pearl Landrith Endowed Professor in Memory & Aging at the University of California, San Francisco, Weill Institute for Neurosciences. “Data will be shared quickly and transparently with physicians, patients, family members, researchers, regulators, such as the FDA, and payers, such as the Centers for Medicare and Medicaid Services.”

“ALZ-NET will include people from diverse backgrounds and communities to achieve representativeness beyond populations historically enrolled in clinical trials,” Rabinovici added.

“The Alzheimer’s Association and its partners work tirelessly to ensure access, safety and effectiveness of treatments for patients,” Carrillo said.

How ALZ-NET and clinical trials complement each other

In order to collect clean and comparable data, clinical trials are conducted under very structured, often narrowly defined conditions, where participants belong, for example, to a specific age group, have no other health problems (often common) or are not taking other medications. They usually take their treatments every time, on time. Study participants often benefit from regular testing, medical care, and follow-up.

Once treatments are approved and available for real-world use, patients take them in the context of their real, busy and sometimes messy lives. And this can have a significant impact on treatment outcomes.

ALZ-NET will be designed to grow with scientific and medical advances. As new drugs are approved and implemented in care, they will also be included in ALZ-NET.

“Our understanding of the complexity of Alzheimer’s disease and other dementias continues to evolve, and there are a number of diverse new therapeutic approaches on the heels of amyloid-targeted therapies that will include therapies available to patients and their caregivers,” said Michael S. Rafii, MD, Ph.D., ALZ-NET Co-Principal Investigator and Professor of Neurology at the University of Southern California Keck School of Medicine and Medical Director of the Alzheimer’s Disease Therapeutic Research Institute (ATRI). “ALZ-NET will be an important tool to help us better understand these treatments using real-world evidence.”

Getting off to a good start…by running the IDEAS AND NEW IDEAS studies

ALZ-NET will draw on the expertise and contacts developed through the IDEAS and New IDEAS studies led by the Alzheimer’s Association, as well as the work of other effective disease treatment networks. ALZ-NET is a Registered Provider Network, which will capitalize on more than 1,000 dementia care providers and imaging facilities across the United States created through the IDEAS and New IDEAS studies. Both of these studies focus on investigating the clinical utility of brain amyloid PET scans.

While ALZ-NET will leverage the IDEAS/New IDEAS network, additional sites are needed that have:

  • Expertise in the diagnosis, treatment and care of Alzheimer’s disease and other dementias.
  • Imaging capability, knowledge and experience of ARIA management.
  • Diverse patient populations and strong community relationships.

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