Alzheimer’s Association Launches Data Collection and Sharing Network

The Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) from the Alzheimer’s Association is a new platform that will collect long-term clinical and safety data from patients treated with FDA-approved Alzheimer's disease therapies in real world clinical settings. 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.

ALZ-NET partner organizations include the American College of Radiology, Critical Path Institute, Department of Biostatistics at Brown University School of Public Health and American Society of Neuroradiology, along with other clinical research and imaging experts.

The goal of ALZ-NET is to improve patient care and outcomes, and inform Alzheimer's treatment practices, including helping us better understand and remediate health disparities, by tracking how people from all backgrounds and communities respond to novel FDA-approved Alzheimer's therapies.

A national system to collect and share drug safety and effectiveness is essential since the Alzheimer's treatment landscape dramatically changed with FDA accelerated approval of aducanumab in June 2021, and as many late-stage clinical trials are expected to report out 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 care that provides the most benefit to people living with the disease and their caregivers, in all communities," said Maria C. Carrillo, PhD, Alzheimer's Association chief science officer and ALZ-NET co-principal investigator. "In collaboration with partners and scientific leaders, we are looking to develop the future of Alzheimer's and dementia treatment and diagnostics."

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 prime example of our commitment to improve care and clinical readiness, and support innovative drug discovery," Carrillo said. "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."

"ALZ-NET will gather real-world clinical practice data and outcomes, including treatment effectiveness and side effects," said Gil D. Rabinovici, MD, ALZ-NET co-principal investigator and Edward Fein and Pearl Landrith Endowed Professor in Memory & Aging at the University of California, San Francisco, Weill Institute for Neurosciences. "The 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 a variety of backgrounds and communities to achieve representativeness beyond the populations historically enrolled in clinical trials," Rabinovici added.

"The Alzheimer's Association and its partners are working tirelessly to ensure access, safety and efficacy of treatments for patients," Carrillo said.

In order to gather clean, comparable data, clinical trials are conducted in highly structured, often narrowly defined conditions where participants are, for example, only in a specific age range, don't have other (often common) health conditions or are not taking other drugs. They usually take their treatments every time, on time. Study participants often get regular testing, medical care and follow-up.

ALZ-NET will be designed to grow with scientific and medical advancements. 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 treatment approaches on the heels of amyloid-targeting therapeutics that will comprise the therapies available to patients and their caregivers," said Michael S. Rafii, MD, PhD, 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 Therapeutic Research Institute (ATRI). "ALZ-NET will be an important tool to help us better understand these treatments using real-world evidence."