August 27, 2026

CLARiTI Connect is a newsletter distributed by the CLARiTI administrative teams at UW–Madison and the National Alzheimer's Coordinating Center. CLARiTI Connect contains current information about study progress, operations updates, news and training opportunities. Thank you for connecting!

FDA approves Tau PET Tracer MK-6240 (now Tauklarify)

Dear colleagues and partners,

I'm delighted to share some terrific news: the FDA has approved MK-6240, now TAUKLARIFY™ (florquinitau F 18 injection), for tau PET imaging in adults with cognitive impairment being evaluated for Alzheimer's disease.

Over the past several years, investigators, imaging and radiochemistry teams, industry partners, and research participants across many institutions have contributed to the development and validation of MK-6240 and to our understanding of its value for detecting and tracking tau pathology. This milestone is particularly exciting for the CLARiTI community, where MK-6240 is being used at 19 sites as part of our multisite imaging effort.

MK-6240 now joins Flortaucipir (FTP) as an FDA approved tau tracer. The transition of MK-6240 from an investigational research tracer to an FDA-approved diagnostic agent represents an important milestone for tau PET and the broader Alzheimer's disease field. Although commercial availability is still ahead, this approval is a significant step toward making this powerful imaging technology more broadly available to patients and clinicians.

Importantly, our workflow and process for CLARiTI will not change with this approval. Because we are using this tracer in a research context, we will continue under our current IND framework.

Congratulations to the many members of the CLARiTI community and the broader field who have contributed to this work—and especially to the research participants whose commitment has made these advances possible.

You can read the Lantheus announcement and the Enigma Biomedical announcement.

- Sterling

Study Updates

CLARiTI Subawards and Letter of Assurance

CLARiTI has received its Notice of Award for Year 3! On Tuesday, August 18, a Letter of Assurance was sent to all sites with anticipated site budget for the upcoming grant year (September 1, 2026 - August 31, 2027).

To help maintain study momentum and avoid disruption to participant-facing and other ongoing CLARiTI activities, we ask sites, to the extent permitted by your institutional policies, to continue activities under the current CLARiTI scope of work until the subaward modification has been executed.

Period Dates

Invoicing Instructions

Notes

Sept. 1, 2025 - August 31, 2026

Personnel expenses, outreach, and procedural costs occurring during this period should be invoiced against the current subaward.

Sites will have until November 29th to sent the FINAL invoice to the UW RSP Office for processing. Final invoice should be marked as such.*

Sept. 1, 2026 - August 31, 2027

Personnel expenses, outreach, and procedural costs occurring during this period should be held until the current subaward has been modified with the new budget and funding for Year 3. The same terms will apply.

Subaward modifications are being prepped at the University of Wisconsin and will be sent out soon.

* Be sure to enter final data for the current grant year, through August 31, 2026. Individual site invoice supplementary statements will be sent out the week of October 5th for final invoices. This will give us time to work through any issues in advance of the November 29th due date for final advances.

CLARiTI by the Numbers: Enrollment Update

Thank you to our study sites for your continued dedication to CLARiTI. The leaderboard below ranks each ADRC by numbers of enrollments and highlights key metrics including cognitive impairment status, representation from populations disproportionately impacted by ADRD (URP), and brain donation enrollment.

We are excited for the upcoming grant year as we build on the tremendous progress made to date and move ever close to our goal of enrolling 2,000 participants.

Site Shout-Outs

The sites listed below have been outstanding in achieving the metrics noted in the table. Kudos to all and keep up the great work!

Kudos!

Site

Metric Achieved

University of Pittsburgh

Highest number of CI participants (n=27)

University of Michigan

Highest percentage of CI participants (86%)

Indiana University

Highest number of URPs (n=56)

Rush University

Highest percentage of URPs (100%)

NYU

Highest number of brain donor (n=89)

UCSD Shiley-Marcos

Vanderbilt

Highest percentage of Brain Donors (100%)

Check Your Site's Metrics

Data as of August 26, 2026

The CLARiTI Enrollment Dashboard is now available — where you can find real-time enrollment metrics and graphics across the entire CLARiTI Program!

Access the CLARiTI Enrollment Dashboard

Click 'View, Audit, Access Data' > 'CLARiTI' > 'Enrollment & Recruitment Dashboard'

CLARiTI Dashboard Access Instructions: (ADRC Portal)

URP Enrollment

Brain Donor Enrollment

Participant Cognition Status

Impairment Categorization for Cognitively Impaired Participants

Data Management Corner

Upcoming Data Freeze - September 1

The next CLARiTI Data Freeze will be on September 1, 2026, alongside the quarterly UDS data freeze.

These last few days prior to the freeze should focus on closing any final queries in the EDC.

General statistics

Number of open / unresolved queries: 136 (unresponded: 21, responded: 115)

Number of closed / resolved queries: 1189

Average time queries remain unresolved: 64.2 days (open queries only)

Average time for query response: 12.8 days (includes open and closed queries)

Average time to query resolution: 25.3 days (closed queries only)

If you have any questions concerning data entry, data query resolution, or accessing the data after the freeze, contact the CLARiTI Data Team at claritidata@uw.edu. The CLARiTI Data Team appreciates all your continued hard work in support of the CLARiTI project!

Study Documents Transition from Box to ADRC Portal - September 11th

CLARiTI Study Documentation is finalizing its transition from Box to the ADRC Portal. The Public folders on Box will be shut down as of September 11th. Moving forward, all study documentation may only be accessed via the ADRC Portal. Links from the CLARiTI website and other communications will now point to this location only.

The ADRC Portal provides a centralized, password-protected location where sites can access the most current version of study documents, improving consistency and ease of access across the consortium.

All sites have received site-specific notifications from CLARiTI Data Management to ensure all necessary users have had the opportunity to establish ADRC Portal access. If you have not checked your ADRC Portal account login, please do so now to ensure no gaps in access and avoid urgent requests.

Confirm account: ADRC Portal and navigate to >> Resources / Documents

Reference: CLARiTI Study Documents Access Instructions

If you have any ADRC Portal account questions, contact the CLARiTI Data Team at claritidata@uw.edu.

EDC v4.2 Training Notice

The CLARiTI EDC has been updated to version 4.2. Please keep an eye out for communications coming soon from your site's project coordinator as this update will require training documentation.

The required training will include information and instructions on a new eCRF - "CLARiTI Follow-up Assessment". This new eCRF will help guide preparations for follow-up visits of existing CLARiTI participants.

Funding Opportunities

CLARiTI REC Fellow Funding Announcement

Call for applications! Opens September 1, 2026

Stay tuned via the REC Scholar listserv for details! The call for applications with detailed information about the opportunity will be sent out September 1, 2026. The application window closes September 31, 2026 at 11:59 pm CT.

Events & Webinars

Register now for CLARiTI Webinar October

8:00 - 9:00 am PT | 10:00 - 11:00 am CT | 11:00 - 12:00 pm ET

CLARiTI mPIs Sterling Johnson and Beth Mormino will give a brief update about CLARiTI Study updates, followed by a deep dive of data trends from the September data freeze, and plans for Yr 3 of enrollment. We will end with an open Q&A session. This webinar is hosted by NACC in support of the CLARiTI study.

Register now

Return of Results (RoR) Core Updates

Training Videos Available!

Return of Results Toolkit to include case vignette training videos detailing different scenarios relevant to the return of research PET scan results. This resource is included in the "Training" folder of the Toolkit, which can be accessed via the ADRC Portal CLARiTI tab.

Dr. Stephanie Simone selected for Developmental Award Program

The CLARiTI Return of Results (RoR) Core Postdoc, Dr. Stephanie Simone, was recently selected for the Michigan ADRC's competitive Developmental Award program, receiving Kickstarter funds to extend and evaluate the CLARiTI RoR protocol implementation at Michigan. Her project, entitled "From Knowledge to Action: Effects of Returning Amyloid Results on Motivation for and Implementation of Health Behavior Change", will evaluate whether locus of control and motivation play a role in objective and subjective change in physical activity after learning CLARiTI PET results. Congratulations, Dr. Simone!

Access Corner

Welcome CLARiTI's First Ambassadors

We are excited to welcome CLARiTI's first Ambassadors, Felecia Bennett-Giles and Evelyn Brooks! Please join us in thanking them for strengthening connections between their ADRC and local community.

Felecia Bennet-Giles

Evelyn Brooks

Wake Forest ADRC

Boston ADRC

Read more here

New CLARiTI Outreach Materials Available

New outreach materials are now available to support recruitment and retention.

Community Conversations: Recording, Q&A Guidance, Trivia worksheet, Participant feedback survey, Site feedback survey

Learn more here
Access material on the ADRC Portal

Spanish Promotional Materials

Learn more here
Access material on the ADRC Portal

These documents are protocol-level approved.

Please submit for site-level approval before disseminating.

Access Core Poster at AAIC

Access Core is proud to have presented a poster at the Alzheimer's Association International Conference (AAIC). We want to extend a big thank you to Dr. Sara Fernandes-Taylor (UW-Madison)as the lead author and Julia Culhane (Mount Sinai) for presenting this poster on behalf of Access Core.

Read more here

Welcome, CLARiTI Program Supervisor, Talia Brach, MPH!

The CAT team has a new Program Supervisor, Talia Brach, MPH. Talia has a background in public health and has previous professional experience in senior living and clinical research for biotech development. While pursuing her bachelors degree and MPH she worked in the lab of Ozioma Okonkwo, and is excited to rejoin the world of Alzheimer's research. Outside of work she loves to spend time with her fiancé (Nick) and cat (Walter) or to out to new restaurants! She will be working at UW Madison alongside the CLARiTI Administrative Team.