Expanding Access to Cognitive Health Biomarker Testing at Home (NCT07594665) | Clinical Trial Compass
By InvitationNot Applicable
Expanding Access to Cognitive Health Biomarker Testing at Home
United States100 participantsStarted 2026-05-18
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring a blood biomarker called p-tau217 at home rather than in a clinic — can you explain what p-tau217 actually tells us about Alzheimer's risk, and whether my current situation is the kind where this result would genuinely change my care?
2The trial is listed as 'enrolling by invitation only' — do you know if I would qualify for an invitation, and if not, is there another way I could access p-tau217 testing through standard care or another study?
3Since this is a Phase NA study focused on whether the at-home workflow is acceptable and completable rather than testing a treatment, what would I actually get out of participating — and would knowing my p-tau217 result lead to any concrete next steps for me?
4The trial covers conditions ranging from normal cognitive aging all the way to Alzheimer's dementia — given where I fall on that spectrum, do you think an at-home biomarker test is the right priority right now, or should we be focused on other evaluations first?
5If I do participate and complete the at-home blood test, how would you and I interpret and act on the result together, and are there any emotional or practical risks I should think about before deciding whether I want to know this information?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability of remote, at-home p-tau217 workflow
Timeframe: From enrollment through study completion (~7 months)
2
End-to-end remote workflow completion rate
Timeframe: From enrollment through study completion (~7 months)