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Expanding Access to Cognitive Health Biomarker Testing at Home

NCT07594665 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-19

No results posted yet for this study

Summary

The goal of this observational study is to learn whether at-home blood biomarker testing for Alzheimer's disease risk is feasible and acceptable in older adults with cognitive concerns. The main questions it aims to answer are:

* Can older adults with subjective cognitive concerns or possible mild cognitive impairment successfully complete a fully remote workflow that includes at-home capillary blood collection, overnight shipping, central laboratory analysis of phosphorylated tau-217 (p-tau217), and remote disclosure of results by a neurologist?
* Is this remote at-home p-tau217 testing workflow acceptable to participants? Participants are adults aged 65 and older who participated in the SHUTi MIND parent study (NCT05565833) and report subjective cognitive concerns or screen positive for possible mild cognitive impairment. Participants will collect a small capillary blood sample at home, return the sample to a central laboratory by overnight shipping for p-tau217 analysis, receive their result during a remote visit with a board-certified neurologist, and complete online surveys at baseline, after results disclosure, and 6 months post-disclosure.

Conditions

  • Mild Cognitive Impairment (MCI)
  • Alzheimer's Dementia (AD)
  • Subjective Cognitive Decline (SCD)
  • Cognitive Aging

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07594665 on ClinicalTrials.gov