When participating in ALZ-NET, you should expect nothing more than your routine visits to your memory care clinician. The information collected at your visits will be securely provided to and stored by ALZ-NET.
We will do our best to make sure that the patient and management information obtained during the course of this research study is kept private. However, we cannot guarantee total privacy. Study information may be given out if required by law. If information from this study is published or presented at scientific meetings, participant’s name and other personal information will not be used. The ALZ-NET database will contain only unique identifiers for patients to protect their identities.
The study investigators will need to know patients’ identities in order to coordinate collection of Medicare claims data for the study. Protected health information (PHI) required for the study will be kept in a database dedicated to PHI, which will be separately housed from the primary database used for analysis purposes. Only the dementia specialist, the ACR data management center, the statistical team coordinating collection of claims data from CMS, and members of the IRB will have access to the records.
Patients that are being treated with the novel FDA approved AD therapies are eligible to enroll in ALZ-NET. A current list of FDA approved therapies can be found here.
The Alzheimer’s Network (ALZ-NET) is a provider-enrolled patient registry that will gather real-world longitudinal clinical practice data and outcomes for patients treated with novel FDA-approved Alzheimer’s disease therapies.
ALZ-NET will collect real-world clinical practice data and outcomes to allow physicians to make more appropriate decisions in patient care as FDA approved therapies become available. Creation of a provider-enrolled patient registry for novel FDA-approved treatments for AD, and for the associated diagnostic tests and biomarkers, is meant to swiftly advance the science, as the pipeline is growing.
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. 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 collect longitudinal clinical and imaging data from all patient participants. Data will include, medical and diagnostic history, medications and AD related treatments, demographic and lifestyle data, cognitive and functional assessments, associated bring imaging, and identifiable information so that health insurance claims data can be analyzed. For a full list of data that is collected, please refer to the summary table of data elements.
The Alzheimer’s Association is the sponsor of the Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET). Maria Carrillo, PhD, Alzheimer’s Association Chief Science Officer, is a Co-Principal Investigator of ALZ-NET, as well as Dr. Gil Rabinovici and Dr. Michael Rafii. The Alzheimer’s Association will participate in guiding and interpreting data analyses and oversight of ALZ-NET.
The American College of Radiology (ACR) is the Operations Center for ALZ-NET and provides the ALZ-NET Investigators with expertise and guidance on imaging related aspects.
The Center for Statistical Sciences of the Brown University School of Public Health will serve as the statistical center for ALZ-NET. Under the direction of Prof. Constantine Gatsonis, statistical faculty and staff provide methodologic expertise, leadership and support in all phases of ALZ-NET, including design, data monitoring, analysis of clinical and medical claims data, and preparation of reports and manuscripts.
The Critical Path Institute (C-Path) will aid ALZ-NET in the collection of regulatory grade data and technological aspects of data reporting.
Clinicians interested in having their site become a participating site in ALZ-NET should first complete the Site Feasibility and Registration Form. Once your submission is reviewed, a member of the ALZ-NET Operations Team will be in contact with you.
The Site Feasibility and Registration form is available to complete and submit at any time. In general, the study will get back to the applicant within a month of submission, however exact timing is dependent upon the volume of responses that ALZ-NET receives. The applicant is not permitted to go onto the next step of site-start up until receiving their formal invitation from the ALZ-NET Operations Team. If you have questions regarding your site’s potential participation, please email the ALZ-NET Operations Team at alz-net@acr.org.
There is no direct cost for sites and clinicians to participate in ALZ-NET.
Yes, there will be monetary compensation for a site’s participation in ALZ-NET. This compensation is provided to help support sites’ time and resources spent during the start-up and data entry processes.
No. All participating sites are required to use Advarra as the IRB of record for ALZ-NET. Local IRB stamp of approval or acknowledgement is allowed, but oversight of study conduct must be ceded to Advarra. Information on how to accomplish this can be found on our IRB information page.
You will need to create an account with cirbi.net and click on your site from the dashboard. All your IRB issued documents can be found on your site page under “IRB Issued Documents” tab. Please contact alznet-regulatory@acr.org or call 1-215-574-3177 with questions.
Sites are required to follow their institutional guidance and requirements regarding HIPAA. Please note that the ICF for this study does not contain a HIPAA section. Sites are reminded that if they do not include their sites HIPAA language into the ICF, that they must use their sites separate HIPAA form. The IRB of record for this study, Advarra IRB, does not require the review of HIPAA forms unless they are included in the ICF (please see their Handbook for reference). However, sites are welcome to submit them for review by the IRB if their local institution requires/recommends that it be reviewed.
No, there is no preference version number. Please use the version that is used in everyday practice at your site.
It is the site’s determination on who administers the assessment to the patient.
No, ALZ-NET does not require the use of a delegation of authority log to document participating site staff. Instead, all staff that have a role on ALZ-NET at a site must fill out the Staff Registration Survey. This survey collects required information on site investigators and staff. This survey also informs the ALZ-NET Operations Team as to which staff need access to Network applications.
ALZ-NET currently provides access to the Functional Activities Questionnaire (FAQ) and AD8 Dementia Screening. These can be found in the Dementia Care Resources page.
Not necessarily. Patients should be seen by their clinician per the standard care that would be provided by the site, even if the patient was not enrolled in ALZ-NET. The data collection time points outlined by the ALZ-NET protocol are just time intervals in which data should be entered, not a mandatory visit schedule.
Clinical Trial Management System (CTMS) is the case registration application for ALZ-NET.
Medidata Rave is the Electronic Data Capture (EDC) application for ALZ-NET.
Any site support staff that will be registering patients and/or uploading patient data will need to obtain access to the necessary applications for ALZ-NET.
A member of the ALZ-NET Operations Team will provide directions to register for a CTMS Account when the time is appropriate. For instructions, please visit the Site Activation page and scroll down to Register for Access to Case Registration Platform (CTMS).
Yes, site staff can utilize their existing Medidata Rave account. This email can be provided in the Staff Registration survey or emailed to alz-net@acr.org. A member of the ALZ-NET Operations Team will add each user profile with a provided email address. Please note that this step is for sites that have been approved to participate in ALZ-NET.
When initially invited to join ALZ-NET in Medidata Rave, an eLearning module must be completed. Please ensure that the eLearning has been completed. If ALZ-NET is still not showing up, please contact the ALZ-NET Operations Team at alz-net@acr.org.
With any questions regarding queries in Medidata Rave, please contact alznet-data@acr.org.
Images and the accompanying image reports that are applicable to a patient’s dementia care will be collected by ALZ-NET. Modalities of interest include MRI, Amyloid PET, and Tau PET.
Sites have options on how to submit images and accompanying reports to ALZ-NET. Images can be submitted through a web-based TRIAD application or a local server hosted application, ACR CONNECT. Both options are secure platforms operated by the American College of Radiology, specifically designed for secure and efficient transfer of imaging data. For detailed information on image transfer, please refer to the Image Submissions Page.