There are over 100 therapies being tested in clinical trials for Alzheimer’s disease (AD) today. With therapies undergoing regulatory review and a growing drug development pipeline, the field is entering a new era of molecular-specific therapies. A national registry represents an opportunity to evaluate the longitudinal outcomes of patients treated with any novel FDA-approved AD therapy in real-world settings, to inform clinical practice.
ALZ-NET will collect longitudinal clinical and safety data for enrolled patients treated with novel FDA-approved AD therapies and will track patient long-term health outcomes (clinical response, health outcomes, and safety), associated with use in real-world settings. ALZ-NET aims to assess the clinical course of individuals from a variety of backgrounds and communities, to achieve representativeness beyond the populations historically enrolled in clinical trials.
ALZ-NET will establish a national, longitudinal registry with expandable platform, allowing for the collection of real-world data from enrolled patients receiving novel FDA-approved AD therapies. ALZ-NET will be a resource for evidence gathering, information sharing, and education across clinical and research communities, encouraging innovative, inclusive research and supporting opportunities to improve care.
All interested sites must complete a site feasibility and registration questionnaire to receive an invitation from ALZ-NET to participate. This site feasibility and registration questionnaire can be located and accessed below. Each participating site must demonstrate the use of a multi-disciplinary dementia care team and optimal medical management. It is expected that participating sites have clinical expertise and an infrastructure to provide novel FDA approved AD therapies consistent with the safety monitoring outlined in applicable FDA approved labels.
Aspects of a qualified participating site include but are not limited to, access to accredited and appropriate radiological services for diagnostic and safety brain imaging, access to infusion services, access to emergency services, and access to standard cognitive, behavioral, and functional assessments used in dementia care.
All essential documents (i.e. protocol, informed consent template, and contract template) will be provided by the ALZ-NET Operations Center once registration approval is granted.
Direct all questions related to ALZ-NET to firstname.lastname@example.org, or call 215-574-3181, ext. 4181.
The Alzheimer’s Association, the American College of Radiology (ACR), the American Society of Neuroradiology (ASNR), the Department of Biostatistics, Brown University School of Public Health and the Critical Path Institute, along with other clinical research and imaging experts, are launching Alzheimer’s National Registry for Treatment and Diagnostics (ALZ-NET).
ALZ-NET is led by a team of co-principal investigators (co-PIs) that have extensive experience in clinical research of Alzheimer’s disease and related dementia (ADRD). The co-PIs have assembled a multidisciplinary group of industry respected and published individuals to form an advisory committee. This advisory committee serves to provide expertise and guidance in their respected domain as it pertains to dementia care and/or clinical research. Under the direction of the co-PIs, ALZ-NET is ideally suited for the ongoing development, conduct, and output of ALZ-NET.
ALZ-NET is governed by a Steering Committee that supports the scientific vision of ALZ-NET by monitoring progress against established timelines, evaluating scientific program initiatives, ensuring publication and dissemination of data, and approving budgets while monitoring financial compliance thereof.
Workgroups and subcommittees will be created under the Steering Committee as needed to perform additional functional roles. Established subcommittees include, but are not limited to, a Data Access Committee, a Communications and Recruitment Committee, an Imaging Committee, and a Data Management Committee.