ALZ-NET is the first network developed specifically for new FDA-approved Alzheimer’s treatments, collecting real-world evidence on drug effectiveness and side effects over a long period of time.
The announcement was made today at the Alzheimer’s Association® (AAIC®) 2022 International Conference in San Diego and virtually. ALZ-NET partner organizations include the American College of Radiology, Critical Path Institute, Department of Biostatistics at Brown University School of Public Health, and the American Society of Neuroradiology, along with other clinical and imaging research experts.
ALZ-NET’s goal is to improve patient care and outcomes and inform Alzheimer’s treatment practices, including helping us better understand and address health disparities, by tracking how people from all backgrounds and communities are responding to new FDA-approved Alzheimer’s therapies.
A national system to collect and share drug safety and effectiveness is essential as the Alzheimer’s treatment landscape changed dramatically with the FDA’s accelerated approval of aducanumab in June 2021, and expect many late-stage clinical trials to be published in the next 12 months.
We are entering a new phase of Alzheimer’s treatment. ALZ-NET is the tool that will help us translate therapies into treatments that provide the greatest benefit to people living with the disease and their caregivers, in all communities. In collaboration with partners and scientific leaders, we seek to develop the future of Alzheimer’s and dementia treatment and diagnosis.”
Maria C. Carrillo, Ph.D., Alzheimer’s Association Scientific Director and ALZ-NET Co-Principal Investigator
Similar successful networks for heart disease, cancer, HIV/AIDS and multiple sclerosis have allowed 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 care and clinical readiness, 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, as it creates opportunities for evidence gathering, information sharing and education.”
What will ALZ-NET collect and produce?
“ALZ-NET will collect data and outcomes from real-world clinical practice, including treatment efficacy and side effects,” said Gil D. Rabinovici, MD, ALZ-NET Co-Principal Investigator and Endowed Professor of ‘Edward Fein and Pearl Landrith in Memory and Aging. at the University of California, San Francisco, Weill Institute for Neuroscience. “Data will be shared quickly and transparently with doctors, 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 different backgrounds and communities to achieve representativeness beyond populations historically enrolled in clinical trials,” Rabinovici added.
“The Alzheimer’s Association and its partners are working 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 highly structured, often narrowly defined conditions, where participants are, for example, only in a specific age range, have no other health problems ( often common) or are not taking other drugs. They tend to take their treatments every time, on time. Study participants often receive regular testing, medical care, and follow-up.
Once treatments are approved and available for use in the real world, patients take them in the context of their real, busy and sometimes messy lives. And this can have a significant impact on treatment results.
ALZ-NET will be designed to grow with scientific and medical advances. As new drugs are approved and introduced into care, they will also be incorporated into ALZ-NET.
“Our understanding of the complexity of Alzheimer’s disease and other dementias continues to evolve, and there are a number of new and diverse treatment approaches beyond 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 Institute of Alzheimer’s Therapeutic Research (ATRI). “ALZ-NET will be an important tool to help us better understand these treatments using real-world evidence.”
Getting it up and running… making the studies IDEAS AND NEW IDEAS work
ALZ-NET will build on the experience and contacts developed through the IDEAS and New IDEAS studies led by the Alzheimer’s Association, and the work of other successful disease treatment networks. ALZ-NET is an enrolled provider network, which will capitalize on the more than 1,000 dementia care providers and imaging facilities in the US created through the IDEAS and New IDEAS studies. These two studies focus on investigating the clinical utility of brain amyloid PET scans.
Although ALZ-NET will take advantage of the IDEAS/New IDEAS network, additional sites are needed that have:
- Experience in diagnosis, treatment and care of Alzheimer’s and other dementias.
- Image capability, and knowledge and experience with ARIA management.
- Diverse patient populations and strong community relationships.