Linus Health: Clinical Trials and Cognitive Assessments at CTAD 2025

BOSTON - November 18, 2025 - Linus Health, an AI-driven brain health company pioneering early detection of cognitive impairment and personalized intervention, will present new evidence validating its AI-enabled tools for early detection and trial readiness at the 18th annual Clinical Trials on Alzheimer’s Disease (CTAD) conference, taking place Dec. 1-4 at the Hilton San Diego Bayfront in San Diego. The company’s research highlights the power of its digital cognitive assessment platform to accurately identify early disease indicators, improve patient-centered outcomes, and accelerate recruitment and screening in clinical trials.

Linus Health will present five scientific posters at CTAD 2025, highlighting its leading role in advancing the early detection of cognitive impairment and driving clinical trial innovation. Three of the posters feature new findings on the electronic Person-Specific Outcome Measure (ePSOM) tool, which captures personally meaningful outcomes that matter most to people living with Alzheimer’s disease. Two additional posters focus on Linus Health’s Digital Clock and Recall (DCR) and Digital Assessment of Cognition (DAC) tools, demonstrating their ability to identify Alzheimer’s disease risk and treatment eligibility with high accuracy.

All five Linus Health poster presentations are part of the “Clinical Trials: Cognitive and Functional Endpoints” and “Cognitive Assessment and Clinical Trials” sessions at CTAD, which take place on Thursday, Dec. 4, from 7:15 a.m. to 5 p.m. in the Indigo Ballroom (Level 2).

Titles and highlights from the poster presentations include:

• P313: Meaningful benefits in global AD trials: feasibility, applicability, and user acceptability of the ePSOM tool in Japanese memory clinics
  Presenting interim data that demonstrate ePSOM’s feasibility, high acceptability, and cultural adaptability, supporting its use in multinational Alzheimer’s disease trials.

Authors: Atsushi Iwata, MD, PhD; Hisatomo Kowa, MD, PhD; Yuki Takeda, MD; Stina Saunders, PhD; Himanshi Malik, MSc; Claudio Toro-Serey, PhD; Ali Jannati, MD, PhD; Sean Tobyne, PhD; Alvaro Pascual-Leone, MD, PhD

• P315: Identifying individually defined treatment priorities sensitive to change in cognition

Findings show that self-reported confidence in personally defined areas such as memory and composure tracks with cognitive impairment status, indicating ePSOM’s sensitivity to early cognitive change beyond traditional patient-reported outcome measures. 

Authors: Stina Saunders, PhD; Claudio Toro-Serey, PhD; Ali Jannati, MD, PhD; Sean Tobyne, PhD; Craig Ritchie, PhD; Sarah Gregory, PhD; Miles Welstead, PhD; Alvaro Pascual-Leone, MD, PhD

• P340: The Digital Clock and Recall identifies eligible candidates for Alzheimer’s disease–modifying treatment
  The three-minute DCR assessment reliably identifies patients who are cognitively impaired and likely amyloid-positive, and thus treatment-eligible, providing a rapid and scalable tool for clinical trial recruitment and accelerating clinical workflows for prescribing disease-modifying treatments.

Authors: Ali Jannati, MD, PhD; Karl Thompson, MSc; Claudio Toro-Serey, PhD; Connor Higgins, MSc; John Showalter, MD; David Bates, PhD; Alvaro Pascual-Leone, MD, PhD; Sean Tobyne, PhD

• P343: Prediction of plasma p-tau217 status and Alzheimer’s risk with the remote-ready Digital Assessment of Cognition
  The seven-minute DAC assessment accurately predicts p-tau217 blood biomarker status, enabling scalable, remote screening for potential Alzheimer’s disease pathology, including in cognitively unimpaired individuals, in clinical trials and community brain health assessments.

Authors: Ali Jannati, MD, PhD; Karl Thompson, MSc; Daniel Schulman, PhD; David Libon, PhD; Rod Swenson, PhD; John Showalter, MD; David Bates, PhD; Alvaro Pascual-Leone, MD, PhD; Sean Tobyne, PhD

• P306: Worse cognitive performance and poorer quality of life are associated with lower self-reported confidence in accomplishing personal priorities: the utility of the electronic Person-Specific Outcome Measure (ePSOM) tool.
  Findings highlight ePSOM’s ability to capture outcomes that reflect what matters most to people living with Alzheimer’s disease, validating the test's effectiveness and supporting its use as a patient-centered endpoint aligned with evolving regulatory guidance.

Authors: Stina Saunders, PhD; Claudio Toro-Serey, PhD; Ali Jannati, MD, PhD; Sean Tobyne, PhD; Craig Ritchie, PhD; Sarah Gregory, PhD; Miles Welstead, PhD; Alvaro Pascual-Leone, MD, PhD

“Digital assessments that can both detect subtle cognitive changes and reflect what truly matters to patients are critical to advancing clinical research and care,” said John Showalter, MD, MSIS, chief operating officer of Linus Health. “Our findings presented at CTAD will show how our AI-enhanced tools can identify Alzheimer’s risk earlier and accelerate the pipeline for disease-modifying treatments by improving trial efficiency and diversity.”

In addition to its poster presentations, Linus Health is pleased to announce that a manuscript entitled “Concurrent detection of cognitive impairment and amyloid positivity with a multimodal machine learning-enabled digital cognitive assessment,” led by the clinical and data science teams, has been accepted for publication in Alzheimer’s Research & Therapy and will be published online soon (after which, it can be viewed at: https://doi.org/10.1186/s13195-025-01913-5). 

The study demonstrates that Linus Health’s tablet-based DCR assessment can, in 3 minutes, accurately detect cognitive impairment and estimate amyloid positivity, highlighting a powerful new approach for earlier identification of Alzheimer’s disease-related brain changes. By showcasing how advanced digital cognitive assessments can enhance brain health screening in routine clinical workflows, this work underscores the potential of scalable, AI-enabled tools to support timely diagnosis and intervention for people at risk of MCI and dementia due to AD.

Linus Health will host meetings at CTAD with life sciences partners throughout the conference to discuss how its digital tools can be used to advance recruitment, strengthen outcome measures, and generate real-world evidence in Alzheimer’s research. CTAD attendees can also visit Linus Health’s virtual booth to learn more about the company’s solutions.

“CTAD brings together leading minds focused on Alzheimer’s research and innovation,” said David Bates, PhD, CEO and co-founder of Linus Health. “Our work presented here demonstrates how technology-enabled, person-centered assessments can support early detection, appropriate selection to reduce costs and enhance trial outcomes, and ultimately lead to better brain health for people worldwide by using clinically validated AI to deliver objective, equitable, and personalized insights that empower earlier action.”

Click Here to schedule a meeting with Linus Health onsite at CTAD 2025.

About Linus Health
Linus Health is a Boston-based digital health company focused on transforming brain health for people around the world. By advancing how we detect and address cognitive and brain disorders — leveraging cutting-edge neuroscience, clinical expertise, and artificial intelligence — our goal is to enable a future where people can live longer, healthier lives with better brain health. Linus Health’s digital cognitive assessment platform delivers a practical means of enabling early detection; empowers providers and researchers with actionable insights, and supports individuals with personalized action plans. We are proud to partner with leading healthcare delivery organizations, research institutions, and life sciences companies to accelerate more proactive intervention and personalized care in brain health. To learn more about our practical solutions for proactive brain health®, visit www.linushealth.com or follow Linus Health on LinkedIn.

Media Contact
Tara Stultz (Amendola Communications for Linus Health)
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