Expanding Access to Cognitive Health Biomarker Testing at Home

Enrolling by invitation

Conditions studied: Mild Cognitive Impairment (MCI), Alzheimer's Dementia (AD), Subjective Cognitive Decline (SCD), Cognitive Aging

In brief

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.

Key facts

Study ID

NCT07594665

Run by

University of Virginia

People needed

100

Starts

2026-05-18

Expected to finish

2028-01-31

Last updated by the study team

2026-05-19

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 65 years or older
• Active participant in the SHUTi MIND parent study (UVA IRB-HSR #220077)
• US resident
• Able to read and speak English
• Regular access (at least twice weekly) to and willingness to use a computer and the Internet, including email
• Endorsement of subjective cognitive concerns or possible mild cognitive impairment, based on TICS screening
• Completed the 24-month post-assessment for the SHUTi MIND study, or at least 90 days since the post-24-month assessment was due

You may not qualify if…

• Severe cognitive impairment that would preclude informed consent or completion of study procedures
• Inability or unwillingness to perform at-home capillary blood collection or to participate in remote results disclosure
• No cognitive concerns

Where it is running

• University of Virginia, School of Nursing — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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