Alzheimer's National Registry for Treatment and Diagnostics(ALZ-NET) — ALZ-NET  

Alzheimer Disease Clinical Trial

Official title: Alzheimer's National Registry for Treatment and Diagnostics

Status Recruiting

Clinical Trial Summary

The Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) will collect longitudinal clinical and safety data for enrolled patients being evaluated for or treated with novel FDA-approved Alzheimer's disease (AD) therapies. ALZ-NET is a longitudinal registry with an expandable platform, designed to grow with scientific and medical advancements. As new treatments are approved and implemented in care, ALZ-NET will track the long-term health outcomes associated with their use in a real-world setting. ALZ-NET is a resource for evidence gathering, information sharing and education across clinical and research communities, encouraging innovative research and supporting opportunities to improve clinical care delivery. All participating physicians and site staff will complete comprehensive training to ensure adherence of data requirements and registry timelines.

Clinical Trial Description

ALZ-NET is collecting longitudinal clinical and safety data for enrolled patients that are being evaluated for or being treated with novel FDA-approved AD therapies. ALZ-NET is a longitudinal registry with an expandable platform, designed to grow with scientific and medical advancements. As new treatments are approved and implemented in care, ALZ-NET will track the long-term health outcomes associated with their use in a real-world setting. ALZ-NET aims to assess the clinical course of people from a variety of backgrounds and communities, to achieve representativeness beyond the populations historically enrolled in clinical trials. 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 clinical care delivery.

ALZ-NET will align with the following objectives:

• Collect baseline and longitudinal patient data, including measures of cognition, function, and long-term safety.

• Collect and archive diagnostic, neuroimaging, genetic and fluid biomarkers.

• Track health outcomes and resource utilization through existing databases.

• Share deidentified data, images and biosamples with the research community and other stakeholders.

All participating physicians and site staff will complete comprehensive training to ensure adherence of data requirements and registry timelines. ALZ-NET will collect longitudinal data through site submitted case report forms and payer claims. Additional objectives of ALZ-NET are to establish a biorepository of plasma, CSF and DNA samples and to archive brain images from participants who consent to these optional elements.

In addition to the aims and objectives outlined within this protocol, ALZ-NET will serve as a backbone registry and platform for collection of regulatory grade data and collaboration with affiliated studies. Affiliated studies are thoroughly reviewed by the ALZ-NET Steering Committee before receiving affiliation approval. ALZ-NET will allow for seamless co enrollment of participants that are being evaluated for or receiving a novel FDA-approved treatment for AD. This collaboration structure is designed to reduce the operational burden of participating sites and patients. ;

Related Conditions & MeSH terms

• Alzheimer Disease

• NCT number: NCT06170268
• Study type: Observational [Patient Registry]
• Source: Alzheimer's Disease and Related Disorders Association, Inc
• Contact: ALZ-NET Operations Team
• Phone: 215-574-3181
• Email: alz-net@acr.org
• Status: Recruiting
• Start date: October 20, 2022
• Completion date: December 2032