National Alzheimer's Coordinating Center
National Alzheimer's Coordinating Center
The NIA Alzheimer’s Disease Research Centers Program
National Alzheimer’s Coordinating Center

UDSv4 Pilot

The National Institute on Aging (NIA), the National Alzheimer’s Coordinating Center (NACC), and the Alzheimer’s Disease Research Centers (ADRC) Clinical Task Force (CTF) have worked over the past several years to update the Uniform Data Set (UDS) forms from version 3 to version 4. The changes, which impact most of the UDS forms, are complete and are ready to be piloted at ADRCs. This pilot will be an excellent opportunity for sites to become familiar with the new UDSv4 forms and practice submitting data before it becomes a requirement. In addition, pilot sites can provide valuable feedback that NACC will incorporate into the formal UDSv4 roll-out.

Purpose of the Pilot

The UDSv4 Pilot will focus on in-person Initial Visit Packet (IVP) forms. The goal of this pilot is to assess the usability and functionality of the following aspects of the forms:

  1. Administering the new UDSv4 forms, new questions, and new criteria

  2. Introducing new data collection and submission options for UDSv4

  3. Assessing the time it takes to administer the UDSv4 IVP versus the UDSv3 IVP

    Centers currently collecting voice recordings of the neuropsychological testing can also practice doing so with the UDSv4 administration to assess the impact on timing it will add to the UDSv4 battery

  4. Identifying implementation challenges with electronic data capture (EDC) via REDCap

We are eager for your feedback on the pilot. This feedback will be used by the CTF and NACC to update UDSv4 guidance documentation and training resources in response to ADRC feedback. Please note that the intent of the pilot is not to change the UDSv4 forms' content. See below for information on how your feedback will be collected.

Pilot Scope

IRB Approval

To participate, ADRCs will submit the UDSv4 IVP forms to their local IRB for approval before administration can commence. NACC will provide these forms to all ADRCs who volunteer for the pilot. If requested by your IRB, NACC can also provide drafts of the UDSv4 Guidebooks, which offer additional guidance on how to administer the UDSv4.

Pilot Data Storage

ADRCs are not expected to update their databases to store UDSv4 Pilot data locally during the pilot. NACC will provide a Data Element Dictionary (DED) which will include all the necessary variables to be able to submit data via any of the three submission methods listed below. Data from the pilot will be housed in a temporary “sandbox” separate from UDSv3 longitudinal data because the data may be incomplete if the pilot results in changes to the UDSv4 forms. Digital voice recording will not be collected by NACC during the pilot and can be locally stored or destroyed.

Submission Options

This pilot will accept submissions to a “UDSv4 Pilot Sandbox”, acting as a temporary database, via one of three submission options.

Learn more about submission options here

Data submission for this pilot will not include data quality checks.

View a demo of the new submission process:

Updated Coding Guidebooks

Drafts of the UDSv4 Guidebooks will be provided to pilot sites for use when administering the UDSv4 forms. The CTF is prepared to make necessary changes to the UDSv4 Coding Guidebooks in response to pilot feedback.

Forms Included in the Pilot

UDSv4 administration during the pilot will only include the forms below which have changes from UDSv3. You may preview all forms on this page.

FormDescription
A1Participant Demographics
A1aSocial Determinants of Health
A2Co-participant demographics
A3Participant Family History
A4aAD-Specific Drug Treatment
A5/D2Participant Health History
B1Evaluation Form: Physical
B3UPDRS-Parkinson's
B8Evaluation Form: Neurological Examination Findings
B9Clinical Judgement of Symptoms
C2Neuropsychological Battery Test Strongly recommend conducting digital voice recording to practice/assess timing
D1aClinical Diagnosis
D1bBiomarkers and Etiological Diagnosis

Expected Changes in Diagnoses

There may be a change in diagnosis from UDSv3 to UDSv4 for some participants, especially those who were diagnosed with MCI or “impaired, not MCI” in UDSv3. In addition to updates in criteria, two new diagnosis categories have been added in UDSv4: “subjective cognitive decline” and “mild behavioral impairment”. NACC and the CTF plan to analyze diagnostic shifts involving the two additional diagnostic categories. Over the coming year, NACC and the CTF will work on a manuscript to report findings.

Pilot Feedback Collection

We are eager for your feedback on the pilot. This feedback will be used by the CTF and NACC to update UDSv4 guidance documentation and training resources in response to ADRC feedback. Please note that the intent of the pilot is not to change the UDSv4 forms' content.

To collect feedback about the pilot, NACC will develop a REDCap survey to be completed by each ADRC’s UDSv4 Pilot contact.

Participating sites will be asked to gather feedback from all the following groups of personnel, and then submit the collected feedback via the REDCap survey.

  • Testers and clinicians on clinician-facing forms
  • Participants on participant-facing forms
  • Data core members on the UDSv4 Data Element Dictionary (DED) and UDSv3 to UDSv4 harmonization

Size, Timing, and Participant Characteristics

To maximally benefit from the pilot, we recommend sites follow all the pilot criteria outlined below. These criteria were developed in collaboration with the CTF and are designed to support sites in gaining familiarity with the UDSv4 content in clinical settings with real participants and with NACC’s new UDS submission options.

  1. The UDSv4 Pilot aims to include at least 10 ADRCs that submit data using REDCap and at least 5 ADRC sites that collect data on PDF forms and bulk upload data via CSV files to the ADRC Portal

  2. It is estimated that the UDSv4 Pilot IVP forms will take 5-6 hours to administer per participant.

  3. Enrolling participants:

    • Each pilot site is asked to include 5 participants with different cognitive diagnoses (including at least one with normal cognition, one with MCI, and one with dementia)
    • Sites should also aim to include a diverse group of participants including those from underrepresented populations to properly pilot the new Form A1a - Social Determinants of Health (SDOH).

  4. It is preferred that UDSv4 pilot visits are done separately from UDSv3 visits. Sites can select participants that are already coming in for UDSv3 and ask them to return shortly afterward for a UDSv4 visit, or participants that have recently completed a UDSv3 visit within the last 3 months can be asked to return for the UDSv4.

Pilot Resources and Support

To facilitate participation in this pilot, ADRCs will be provided with the following resources and support:

Pilot Meetings

  • UDSv4 Pilot Kick-off Meeting – May 16, 2024, registration link will be sent to Centers signed up for the Pilot
  • Mid-Pilot Meeting with CTF and NACC Staff – June 28, 2024, registration link will be sent to Centers signed up for the Pilot

UDSv4 Webinars and Presentations

May 14, 2024 UDSv4 Virtual Clinical Training Workshop

View Q&A From the Training
Forms A1 & A2Presented by Clinical Task Force Member Dr. Greg Jicha of University of Kentucky ADRC.
Form A1aPresented by Clinical Task Force Members Dr. Lisa Barnes of Rush University ADRC and Dr. Megan Zuelsdorff of UW Madison ADRC.
Form A4Presented by Clinical Task Force Member Dr. Teresa Gomez-Isla of Massachusetts ADRC.
Form A4aPresented by Clinical Task Force Member Dr. Suzanne Schindler of Washington University ADRC.
Form A5/D2Presented by Clinical Task Force Member Dr. Aimee Pierce of OHSU ADRC.
Form B3Presented by Clinical Task Force Member Dr. Brad Boeve of Mayo Clinic ADRC.
Form B8Presented by Clinical Task Force Member Dr. Brad Boeve of Mayo Clinic ADRC.
Form B9Presented by Clinical Task Force Member Dr. Kostas Lyketsos of Johns Hopkins ADRC.
Form C2/C2TPresented by Clinical Task Force Members Dr. Lisa Barnes of Rush University ADRC and Dr. Andy Saykin of Indiana ADRC.
Form D1aPresented by Clinical Task Force Members Dr. Jeff Burns of Kansas University ADRC, Dr. Andy Saykin of Indiana ADRC, and Dr. Kostas Lyketsos of Johns Hopkins ADRC.
Form D1bPresented by Clinical Task Force Member Dr. Jeff Burns of Kansas University ADRC.

March 2024 Operationalizing "Impaired, not MCI" in UDSv4 Webinar

This hour-long webinar addressed operationalizing "Impaired, not MCI" vs MCI in the UDSv4. We opened with an overview of the item on UDSv4 Form D1a. Each speaker gave a case presentation, with ample time at the end for discussion and audience Q&A. This webinar was hosted by NACC and the ADRC Clinical Core Steering Committee as a part of our UDSv4 Webinar Series. Watch here

February 2024 UDSv4 Cognitive Task Force Webinar

Presenter Dr. Kostas Lyketsos uses a case-based approach to ratings of neuropsychiatric symptoms and mild behavioral impairment on Form D1a and related forms. Background to the concept of MBI and its importance as an early symptom of dementia is also shared. Watch here

  • Data Submission Demonstration Videos - Links Forthcoming
  • NACC UDSv4 Pilot Onboarding Checklist - By May 13, 2024. It will be provided to Centers signed up for the Pilot.
  • UDSv4 Initial Visit Packet in PDF - By May 13, 2024. It will be provided to Centers signed up for the Pilot.
  • Draft UDSv4 Coding Guidebooks - By May 13, 2024. They will be provided to Centers signed up for the Pilot.
  • Data Element Dictionaries - By May 31, 2024. They will be provided to Centers signed up for the Pilot.
  • Final UDSv4 Pilot Report - A report of pilot findings will be written to summarize form feedback from participating sites along with plans for changes in response to the feedback.

UDSv4 Pilot Timeline

Roles for NACC, ADRC, or Both

CategoryTaskAprilMayJuneJuly
Pilot Kick-OffADRCs invited to join pilot, receive UDSv4 forms and draft coding guidebooksNACC
OnboardingPilot sites gain IRB approval and attend or watch onboarding training & preboarding meeting, receive data element dictionaries Both
Pilot Period & ReportingADRCs administer pilot forms and submit data (June 1 - July 31, 2024)ADRC
ReportingMid-pilot meeting, June 28, 2024Both
ADRCs provide pilot feedback ADRC

NACC Community Forum

Join the latest discussions about the UDSv4 Pilot on the NACC Community Forum!

If you are participating in the UDSv4 Pilot, you should have received an invitation to join Discourse, NACC’s moderated forum tool. Accept the invitation and create login credentials to gain access to Discourse.

Once you have access, click here to go to the UDSv4 Pilot section of Discourse. In the NACC Community Forum, you can:

  • Add new discussion topics
  • Reply to existing topics
  • Ask questions
  • Get support
  • Help other members of the ADRC Program community

Note: The NACC Community Forum is currently invitation-only and only open to NACCID and UDSv4 Pilot Participants. If you are part of either pilot program and did not receive an invitation to join Discourse, or need to add someone else from your team, please contact nacchelp@uw.edu.

Need Help?

API Questions

Learn more about programmatic access on the Data Platform Page

General Questions

Please direct all other questions related to the UDSv4 Pilot to: naccmail@uw.edu