Alzheimer's Association Launches ALZ-NET Registry for Study of New Treatments for Alzheimer Disease in Real-World Setting
ALZ-NET is a national network of sites that will be collecting real-world evidence on people being treated with novel treatments approved by the Food and Drug Administration for the treatment of Alzheimer disease. This clinical registry is a model that has been used in other disease states, including epilepsy, stroke, multiple sclerosis, cancer, and cardiovascular conditions.
Registries such as ALZ-NET have proven useful for gathering clinical real-world data on treatment safety and efficacy, which can be used to develop new standards of care. Importantly, this type of real-world registry allows study of these treatments in a broader and more diverse population than seen in clinical trials.
The goals of the ALZ-NET registry study include developing a multisite network to collect real-world evidence, to build and implement resources to provide an environment of clinical readiness as more treatments become available, to collect patient data once the decision is made to initiate treatment. Discussions are ongoing regarding whether participants could be enrolled prior to the decision to start treatment with 1 of these new agents, now approved or expected to be approved soon.
ALZ-NET will include resources for collection and archiving clinical imaging, biomarker data, biospecimen information, outcome measures, and resource utilization. An Institutional Review Board protocol has been approved and the infrastructure has been built for sites to begin participating in this registry. There are 7 vanguard sites already activated that include psychiatry, neurology, and geriatrics clinics in both private practice and academic settings.
ALZ-NET is structured to support collaboration with affiliated studies. Baseline data on participants or will be taken when participants begin treatment and follow up data will be input every 6 to 12 months afterwards, but clinical follow-up care does not have to occur at those timepoints alone. Affiliated studies may use the data from ALZ-NET and may also include additional data per their study protocols in ALZ-NET. Arrangements are being made for an addendum consent for such affiliated studies.
For ALZ-NET the American College of Radiology and its Critical Path Institute will provide regulatory oversight, Brown University will provide data analytics, and arrangement have also been made for data dissemination. In addition, ongoing discussions are occurring for use of ALZ-NET outside the US in partnership with other Alzheimer organizations.
The platform for data entry requires users to be authenticated and uses software that integrates with electronic health records in a manner that is compatible with the Health Information and Portability Accountability Act (HIPPA).
Dr Mary Carillo, president of the Alzheimer's Association, noted that, “At the Alzheimer’s Association, we ae invested in this because we believe it is a good way forward toward our shared vision of trying to ensure that more effective treatments reach our families more quickly and safely, which we know is a common goal of the Alzheimer community.”