What You Should Know:
– Advancements in accelerating early Alzheimer’s disease (AD) screening and access to care, proven from three diverse community pilot initiatives, were presented today during a podium presentation at the Alzheimer’s Association International Conference® 2025 (AAIC). The study, entitled “Remote Collection of Biomarkers for Alzheimer’s Disease and Related Disorders,” validated Neurogen’s new ecosystem, which brings together the first in-home blood biomarker testing and a cognitive assessment with virtual care.
– The study findings reveals that this ecosystem has the potential to reduce the time from the earliest development of symptoms to care by 4.5 years, significantly breaking down barriers to early detection and treatment of Alzheimer’s disease. The study also validated a strong correlation between the TASSO, a non-invasive, needle-free blood collection method, and traditional phlebotomist blood draw/capillary collection, suggesting TASSO’s potential to successfully triage patients.
Urgent Unmet Need for Early AD Detection
An estimated 40% of Americans aged 65 and older (over 16 million people) experience some form of memory impairment. Yet, fewer than 8% of older adults with Mild Cognitive Impairment (MCI) ever receive a formal diagnosis, leaving 92% without answers or access to early intervention. On average, there is a staggering 6- to 8-year delay from symptom onset to diagnosis, even though current treatments are most effective in the earliest stages of disease. Further compounding this, fewer than one in five Alzheimer’s diagnoses in the U.S. currently involve biomarker testing due to accessibility and clinical expertise gaps. These data underscore an urgent call to transform how Alzheimer’s and cognitive decline are detected and managed, especially as the aging population grows.
“Neurogen’s ecosystem is built to meet the urgent global demand for faster adoption of breakthrough testing technologies for early detection of AD. Our mission is to give everyone equal access to cutting-edge technology to detect Alzheimer’s early—when treatment can make the greatest impact on the course of people’s lives,” said Elisabeth Thijssen, PhD, Chief Scientific Officer, Neurogen Biomarking and the session presenter.
Study Design and Results
The findings stem from three free community events targeting people aged 50 and older, held at local hospitals in Chicago, IL; Flint, MI; and Coldwater, MI. Participants were recruited through community engagement, traditional and social media, and outreach to health and wellness organizations.
Screening Process:
- Participants began with an advanced digital cognitive assessment and a brief lifestyle survey.
- Every participant underwent a traditional IV venous blood draw by a licensed professional, with the TASSO collection offered as an optional addition.
- All samples were preserved via ambient shipment, maintaining integrity without refrigeration or freezing.
- IV samples were analyzed using the ALZpath P-tau217 assay, a validated ultrasensitive biomarker test correlating closely with Alzheimer’s pathology.
- Testing was conducted in CLIA- and CAP-certified laboratories, ensuring clinical accuracy, with results available within days. Telehealth counseling with a board-certified neurologist was provided for follow-up if needed.
Key Study Results (from 455 participants):
- Demographics: 66% women, average age 67, 45% White/Caucasian, 39% Black/African American.
- Elevated P-tau217: 26% of participants had elevated P-tau217 concentrations.
- Cognitive Impairment: 80% showed some form of cognitive impairment, aligning with expectations.
- TASSO Accuracy: TASSO identified elevated P-tau217 with 88% accuracy, meeting performance requirements for AD triaging.
- Accelerated Intervention: The Neurogen ecosystem reduced the time from cognitive concerns to intervention by 4 years—changing the standard time from emergence of concerns from 3-6 years to 4 months-1.5 years.
- Follow-up Care: Participants with elevated test results received telehealth follow-up care from board-certified neurologists within days.
Neurogen’s online ecosystem offers in-home blood biomarker testing for phosphorylated (p-tau217) and advanced digital cognitive testing for people with memory concerns. Results are guided by board-certified neurologists via telehealth. The platform is currently in beta test and preparing for national launch, offering a potential solution to meet the urgent global demand for faster adoption and equitable access to breakthrough testing technologies for early detection of AD.
