NCT07594665

Expanding Access to Cognitive Health Biomarker Testing at Home

Enrolling by Invitation
Not specifiedAges 65+Observational
University of Virginia
~100 participants
Updated 2026-05-19 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability of remote, at-home p-tau217 workflow
Measured over From enrollment through study completion (~7 months)
+1 more outcome measured
Mild Cognitive Impairment (MCI)
Alzheimer's Dementia (AD)
Subjective Cognitive Decline (SCD)
Cognitive Aging
1 sites across 1 states
Virginia1

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Acceptability of remote, at-home p-tau217 workflowFrom enrollment through study completion (~7 months)

    Participant-reported acceptability of the fully remote at-home p-tau217 testing and disclosure workflow, measured by a standardized post-disclosure acceptability questionnaire assessing perceived ease of use of the Tasso device, comfort with at-home blood collection, satisfaction with remote results disclosure, perceived burden, and willingness to recommend the workflow to others.

  • End-to-end remote workflow completion rateFrom enrollment through study completion (~7 months)

    Proportion of enrolled participants who complete each step of the fully remote workflow: kit receipt, at-home capillary blood collection using the blood-collection device, return shipment within the time window required for sample stability, and completion of remote results disclosure by a board-certified neurologist.