Goal #1: Advance clinical and translational science

Led by Stanford Drs. Leanne Williams and Laura Hack, and co-authored by Senior Associate Dean for Research and Stanford CTSA Principal Investigator Ruth O’Hara, PhD, a report in&nbsp;Nature Mental Health&nbsp;describes a recent clinical trial that aims to address the cognitive biotype of depression—a subset of patients who experience significant cognitive deficits alongside their depressive symptoms.“This study exemplifies what our CTSA grant is designed to enable—advancing precision medicine in mental health by uniting neurocognitive phenotyping, biomarker stratification, and rigorous trials using CTSA infrastructure,” explained Dr. O’Hara. “It accelerates tailored treatments for the cognitive biotype of depression and establishes a translational model for other neuropsychiatric conditions.”For this trial, the research team used neuropsychological assessments and biomarker evaluations to carefully select patients that met criteria for this type of depression. They then tested the efficacy of a novel treatment - guanfacine immediate release (GIR), an ?2A receptor agonist that affects cognition-related neurocircuitry. Three quarters of the participants receiving this treatment demonstrated a clinical response, exceeding conventional antidepressant response rates. GIR administration also led to significant improvements in cognitive control, global life satisfaction, and quality of life.In addition to the potential benefit to participants with the cognitive biotype of depression, this research represents another step forward for personalized healthcare solutions in mental health.<a href="https://www.nature.com/articles/s44220-025-00510-7" target="_blank" rel="noopener noreferrer">Read the journal article here</a> <a href="https://www.nature.com/articles/s44220-025-00510-7" target="_blank" rel="noopener noreferrer">https://www.nature.com/articles/s44220-025-00510-7</a>

Stanford Center for Clinical & Translational Education and Research (Spectrum)

large_suboozys8yu887eiszh7tp2t4_Precision Medicine iStock-2225232598.jpg

medium_suboozys8yu887eiszh7tp2t4_Precision Medicine iStock-2225232598.jpg

small_suboozys8yu887eiszh7tp2t4_Precision Medicine iStock-2225232598.jpg

thumbnail_suboozys8yu887eiszh7tp2t4_Precision Medicine iStock-2225232598.jpg

suboozys8yu887eiszh7tp2t4_Precision Medicine iStock-2225232598.jpg

Stanford University

Researchers from Stanford Spectrum were recently featured in Nature Mental Health discussing a clinical trial addressing the cognitive biotype of depression. In addition to the potential benefit to participants with the cognitive biotype of depression, this research represents another step forward for personalized healthcare solutions in mental health.

Unlocking New Insights into Depression Treatment Through Precision Medicine

- Any -

Goal #4: Improve clinical research

Alzheimer’s disease, a neurodegenerative disease that affects memory and other cognitive functions, is the leading cause of dementia and affects more than 7 million people in the U.S. Recent developments for AD treatment work by removing excess amyloids, or protein aggregates that can build up to form plaques that impede brain function, from the brain. These promising therapies require accurate early AD diagnosis; they are only effective in the early stages of AD and are ineffective for those with other types of dementia. However, current diagnostic methods primarily include brain tissue examination after death and, for living patients, highly invasive procedures or expensive imaging techniques. Minimally invasive AD tests that can diagnose disease earlier could support anti-amyloid therapy use and serve a wider population of patients. In 2021, Jerry Wang, MD, PhD, an associate professor of pathology at Duke University, and Dr. Bin Xu, a Principal Investigator at NC Central University’s Biomanufacturing Research Institute and Technology Enterprise and an associate professor of pharmaceutical sciences, started conducting research to develop minimally invasive tests (blood- and cerebrospinal fluid [CSF]-based) for earlier AD diagnosis and monitoring disease severity. Their work builds on the recent discovery of changes in tau proteins in the brain, wherein they misfold and are more likely to clump. This clumping leads to symptoms associated with various neurodegenerative diseases, including AD. However, current tests for these tau proteins can only be used on brain tissue from deceased patients to indicate if the patient was affected by AD or other neurodegenerative diseases (e.g., Pick’s disease or corticobasal degeneration) that also lead to dementia. Recent discoveries indicate that misfolded tau proteins can be found in the blood and CSF of living patients with AD, suggesting that early AD diagnosis is possible via identification and detection of AD-specific tau protein biomarkers. Xu collaborates with Ling Wu, MD, PhD, a researcher based at NC Central who is also a Duke/University of North Carolina (UNC) Alzheimer’s Disease Research Center (ADRC) Research Education Core (REC) Scholar. This team first identified several potentially AD-specific tau protein biomarkers through experiments wherein they examined brain tissue from deceased individuals with and without AD. Next, Dr. Wang’s team validated these biomarkers by training machine learning software to recognize misfolded tau proteins. Wang and Xu were able to demonstrate that these biomarkers can be used to differentiate AD from other neurodegenerative diseases with similar tau protein behavior and to identify samples with AD-specific mild cognitive impairment, an early stage of AD where cognitive impairment does not interfere with day-to-day life yet. In another study, Andy Liu, MD, MS, an associate professor of neurology at Duke, joined the joint research team to further examine whether one of these identified tau protein biomarkers was sufficient for diagnosing early-stage AD. Using a laboratory test for this biomarker, CSF, and plasma samples from living patients, the joint research team demonstrated that this biomarker could differentiate early-stage AD from cognitively normal participants. However, more work is needed to differentiate early-stage AD from non-AD cognitive impairment. This research program has led to several invention disclosures and Patent Cooperation Treaty (PCT) applications, which support patent applications within the US and internationally. The joint research team is now validating ultrasensitive minimally invasive tests they have developed to identify the presence of these biomarkers in early-stage AD. This work paves the way for earlier and cost-effective detection of AD, which will facilitate treatment.&nbsp;

Duke Clinical and Translational Science Awards

small_From Brain Tissue to Blood Tests.png

thumbnail_From Brain Tissue to Blood Tests.png

From Brain Tissue to Blood Tests.png

Duke University

A Duke University–North Carolina Central University research collaboration is developing minimally invasive blood- and cerebrospinal fluid (CSF)-based tests for earlier Alzheimer’s disease (AD) diagnosis and severity monitoring, addressing the need to identify patients early enough for anti-amyloid therapies to be effective. The team discovered AD-specific misfolded tau biomarkers in brain tissue, validated them with machine learning, and showed that at least one biomarker measured in matched CSF and plasma can distinguish early-stage AD from cognitively normal participants, though further work is needed to separate AD from non-AD cognitive impairment. Multiple invention disclosures and patent filings have resulted, and ongoing validation of ultrasensitive assays aims to deliver lower-cost, more accessible diagnostics across a wider range of clinics.

From Brain Tissue to Blood Tests

X-logo-teal_80x66.png

ri_linkedin_fill_408497d4b5_96748f4451.png

Dr. Jill Urban’s path to impactful research began with an undergraduate degree in mechanical engineering and internships at facilities like Frito-Lay and Palo Verde Nuclear Power Plant. While these roles were valuable, they&nbsp;didn’t&nbsp;ignite her passion. That spark came when Dr. Urban joined a summer internship at Wake Forest studying car crash injuries, where she first explored injury biomechanics—the application of engineering principles to the human body. This experience inspired her to pursue a PhD in biomedical engineering, focusing on translating biomechanics data into real-world safety improvements for athletes. &nbsp;<h4 style="margin-left:0px;">Building Research Foundations with CTSI</h4>The foundation of Dr. Urban’s independent research career was laid through the&nbsp;<a href="https://ctsi.wakehealth.edu/education-and-training/k12-career-development">CTSI KL2 program (now known as the K12 program).</a>&nbsp;This program provided critical protected time, mentorship, and opportunities for networking and skill development, including participation in the&nbsp;<a href="https://ctsi.wakehealth.edu/education-and-training/translational-research-academy">Translational Research Academy</a>. Importantly, the KL2 program opened doors for Dr. Urban to earn a Master of Public Health and introduced her to the principles of public health intervention and community engagement—key elements that now define her work.Following her KL2 experience, Dr. Urban collaborated with Drs. Kristie&nbsp;Foley,&nbsp;Justin Moore,&nbsp;and her mentorship team to secure&nbsp;additional&nbsp;NIH funding via the K25 Career Development Award. Recognizing the need for further data, she applied for the&nbsp;<a href="https://ctsi.wakehealth.edu/funding-opportunities/ignition-funds">Ignition Fund</a>, which provided resources to collect neurocognitive data on youth football athletes. This $5,000 grant played a pivotal role, supplying preliminary data that supported both a PhD student’s F31 application and Dr. Urban’s own R01 grant submission.&nbsp;These strategic uses of CTSI funding demonstrate how targeted support can catalyze research momentum and long-term success.Securing an R01 grant is a milestone for any researcher, and Dr. Urban credits CTSI’s writing resources and mentorship for her success. She&nbsp;participated&nbsp;in the&nbsp;<a href="https://ctsi.wakehealth.edu/education-and-training/kr-writers-series">K&amp;R Writers Series</a>&nbsp;and received expert editing from&nbsp;<a href="https://ctsi.wakehealth.edu/service/scientific-editing-services">CTSI’s writing support specialists</a>—which helped her refine grant proposals and improve communication. In addition, Dr. Urban utilized&nbsp;<a href="https://ctsi.wakehealth.edu/service/research-studios">CTSI’s research studios</a>&nbsp;for early-stage grant planning,&nbsp;benefiting&nbsp;from feedback outside her immediate collaborators. These resources proved invaluable, especially during challenging moments when persistence and strategic refinement led to successful funding after multiple submissions. &nbsp;<h4 style="margin-left:0px;">The Power of Community-Engaged and Implementation Science</h4>Dr. Urban’s research evolved from observational&nbsp;studies to true community-engaged science, collaborating directly with youth football organizations to co-develop interventions that are both&nbsp;feasible&nbsp;and&nbsp;effective.&nbsp;CTSI’s&nbsp;<a href="https://ctsi.wakehealth.edu/program-in-community-engaged-research">Community and Stakeholder Research Engagement Program</a>helped plant the seed for this&nbsp;shift&nbsp;by introducing&nbsp;the idea of working with&nbsp;community partners.&nbsp;Dr. Urban’s research progressed with&nbsp;CTSI's&nbsp;formal&nbsp;and informal guidance, including encouragement to foster and lean into the relationships she had built over many years working with the community in observational research studies.&nbsp;Now, her work focuses on collaboration to achieve safer sports settings and stronger community partnerships.Implementation science principles, championed by&nbsp;<a href="https://ctsi.wakehealth.edu/about-ctsi/ctsa-programs/dissemination-implementation-and-continuous-quality-improvement">CTSI’s Dissemination, Implementation, and Quality Improvement program&nbsp;(DICQI</a>), also inform Dr. Urban’s approach.&nbsp;By systematically assessing organizational readiness and adapting interventions to local contexts, her COACH program (Communities Aligned to Reduce Concussion and Head Impact Exposure) is improving coaching quality and athlete safety, while fostering relationships across high school and youth football communities. &nbsp;<h4 style="margin-left:0px;">Research Outputs and Recognition: Publishing with CTSI Support</h4>With&nbsp;nearly 80&nbsp;publications to her name—including 15–20 stemming from K awards—Dr. Urban’s research impact is clear. She highlights&nbsp;papers&nbsp;demonstrating&nbsp;the influence of&nbsp;practice activities on head impact exposure, foundational to the COACH framework, as some of her most influential works.&nbsp;She brings implementation science and community-engaged principles to her engineering research team, expanding the translational impact of their biomechanics research, and&nbsp;enriching the skillset of the biomechanics and neuroscience&nbsp;PhD and MS students&nbsp;she mentors.&nbsp;Professional write-ups have further elevated her&nbsp;and her team’s&nbsp;visibility in the CTSI newsroom and newsletters. CTSI’s writing support, networking opportunities,&nbsp;implementation&nbsp;science support,&nbsp;and community engagement programs have all contributed to this robust publication record.Read&nbsp;additional&nbsp;articles about Dr. Urban’s research here:<a href="https://school.wakehealth.edu/features/research/keeping-youth-athletes-safe-on-the-field">Keeping Youth Athletes Safe</a><a href="https://school.wakehealth.edu/features/awards-and-recognition-results/dr-jill-urban-and-team-provide-youth-football-safety-event-for-community">Dr. Jill Urban and Team Provide Youth Football Safety Event for Community</a><h4 style="margin-left:0px;"> CTSI: Empowering Researchers for Lasting Impact</h4>Dr. Urban’s story exemplifies “pipeline success”—a journey marked by resilience, mentorship, and embracing new perspectives. She encourages early-career researchers to use CTSI resources, seek interdisciplinary collaboration, and persist through setbacks.&nbsp;“You just have tofind a way to communicate your research the way you feel is best,” she notes, crediting mentors and CTSI’s writing experts for helping her communicate her science effectively.Dr. Urban’s future goals include expanding the COACH framework to other sports and regions,&nbsp;leveraging&nbsp;relationships and networks built through CTSI programs. Scaling up will rely less on traditional advertising and more on community partnership and adaptation—principles at the heart of community-engaged and&nbsp;implementation&nbsp;science.Her motivation&nbsp;remains&nbsp;rooted in the relationships built with the youth football community and a commitment to supporting&nbsp;young&nbsp;athletes. CTSI’s resources and services have been&nbsp;instrumental in&nbsp;every step of the way, from&nbsp;initial&nbsp;research planning to grant writing, data collection, publication, and beyond.Dr. Jill Urban’s journey&nbsp;demonstrates&nbsp;the transformative power of CTSI’s resources and services for investigators at all stages. Whether through career development awards, pilot funding, writing support, research studios, or&nbsp;other&nbsp;programs, CTSI provides the foundation for innovative research that translates knowledge into real-world improvements.For researchers looking to make a difference, CTSI offers a collaborative environment and a wealth of tools to help turn ideas into impactful science—just as it has for Dr. Urban.________________________________If&nbsp;you are interested in collaborating with the Wake Forest CTSI, please review and request our services <a href="https://redcap.wakehealth.edu/redcap/surveys/?s=HN37MPMNJ8EYLH3W">here</a>. If you are considering our pilot program and wish to apply for funding, please find the details <a href="https://ctsi.wakehealth.edu/about-ctsi/ctsa-programs/clinical-and-translational-science-pilot-program">here</a>.

Wake Forest Clinical and Translational Science Institute

large_uvbvepyzg8vf0y28sf5wkktzg_20240713 Atrium Youth Football Safety Clinic Ed 096.jpg

medium_uvbvepyzg8vf0y28sf5wkktzg_20240713 Atrium Youth Football Safety Clinic Ed 096.jpg

small_uvbvepyzg8vf0y28sf5wkktzg_20240713 Atrium Youth Football Safety Clinic Ed 096.jpg

thumbnail_uvbvepyzg8vf0y28sf5wkktzg_20240713 Atrium Youth Football Safety Clinic Ed 096.jpg

uvbvepyzg8vf0y28sf5wkktzg_20240713 Atrium Youth Football Safety Clinic Ed 096.jpg

Wake Forest University Health Services

Dr. Jill Urban transformed her passion for sports injury prevention into impactful research, aided by the Wake Forest Clinical and Translational Science Institute (CTSI). Through their mentorship, training, and funding, she shifted from engineering studies to developing community-focused interventions that improve athlete safety. With nearly 80 publications, Dr. Urban’s work was made possible by Wake Forest CTSI resources, including research support, grant guidance, and collaborative opportunities. Her career demonstrates how their researchers turn scientific interests into real-world change.

Driving Innovation in Injury Prevention: Dr. Jill Urban’s Journey with Wake Forest CTSI Resources

CTSA CCOS

Home

About

CTSA Groups and Meetings

Resources

News

Help

CTSA News

Unlocking New Insights into Depression Treatment Through Precision Medicine

Summary

Article