Expanding Access to Cognitive Health Biomarker Testing at Home

May 15, 2026 updated by: Meghan Mattos, University of Virginia

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Alzheimer's disease (AD) and related dementias are among the most urgent public health challenges, with more than six million Americans currently affected. Early detection is critical to improving outcomes, yet diagnosis is often delayed until symptoms interfere with daily functioning and specialty evaluation is obtained. Blood-based biomarkers, particularly phosphorylated tau-217 (p-tau217), represent a transformative advancement, offering accurate, scalable, and minimally invasive alternatives to cerebrospinal fluid assays and PET imaging. However, their feasibility in remote, population-based workflows remains largely untested.

This study will enroll a prospective, remotely recruited cohort of older adults with subjective cognitive concerns or possible mild cognitive impairment to evaluate the clinical and operational feasibility and acceptability of at-home p-tau217 testing. This project targets individuals at elevated risk for dementia progression but without a formal diagnosis.

After consent, participants will complete brief baseline online surveys and receive an at-home blood collection kit. The kit contains a single-use Tasso capillary blood sampling kit, illustrated written and video instructions, prepaid return packaging, and a customer support contact. Participants self-collect capillary blood from the upper arm and return the sample to a CLIA-certified laboratory (Neurogen Biomarking/AccessDx Laboratory) for p-tau217 immunoassay analysis. All results are reviewed by a board-certified neurologist independent of the study team and classified as positive, negative, or intermediate. Negative results are shared via email, and intermediate or positive results include neurologist disclosure of results to the participant via secure videoconference or telephone, explanation of the meaning and limitations of the result, and, when applicable, recommendation and facilitation of referral for confirmatory testing or specialty evaluation.

Participants complete a post-disclosure acceptability survey within 2 weeks of results disclosure, and a follow-up survey at 6 months post-disclosure, to capture downstream specialty evaluation, confirmatory testing, and treatment initiation. The total per-participant duration is ~6-7 months. By operationalizing a fully remote biomarker workflow, the study aims to inform scalable, patient-centered pathways for early AD diagnosis, especially among rural and underserved populations facing geographic, workforce, and cost barriers to specialty dementia care.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia, School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged 65 years and older residing in the US who were participants in the SHUTi MIND parent randomized controlled trial (UVA IRB-HSR #220077), have completed (or are at least 90 days past due for) the SHUTi MIND 24-month post-assessment, and report subjective cognitive concerns or screen positive for possible mild cognitive impairment on the Telephone Interview for Cognitive Status (TICS).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Older Adults with Cognitive Concerns
Adults aged 65 years and older who are participants in the SHUTi MIND parent study (IRB-HSR #220077), reside in the United States, and report subjective cognitive concerns or screen positive for possible mild cognitive impairment based on the Telephone Interview for Cognitive Status (TICS). Participants undergo at-home capillary blood collection for plasma p-tau217 testing, remote results disclosure by a board-certified neurologist, and longitudinal online surveys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of remote, at-home p-tau217 workflow
Time Frame: From 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.
From enrollment through study completion (~7 months)
End-to-end remote workflow completion rate
Time Frame: From 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.
From enrollment through study completion (~7 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 18, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-HSR 302986

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) are not planned to be shared outside the study team. De-identified aggregate results will be disseminated through peer-reviewed publications and scientific conference presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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