Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170268
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2022-07-07
Brief Title:
Alzheimers National Registry for Treatment and DiagnosticsALZ-NET
Sponsor:
Alzheimers Disease and Related Disorders Association Inc
Organization:
Alzheimers Disease and Related Disorders Association Inc
Study Overview
Official Title:
Alzheimers National Registry for Treatment and Diagnostics
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALZ-NET
Brief Summary:
The Alzheimers 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 Alzheimers 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None