An observational study in Mild Cognitive Impairment (MCI), Alzheimer's Dementia (AD) and Subjective Cognitive Decline (SCD), sponsored by University of Virginia. Enrolling by invitation at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by University of Virginia · Observational
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:
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.
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Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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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).
Exclusion Criteria:
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.
Acceptability of remote, at-home p-tau217 workflow
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.
Time frame: From enrollment through study completion (~7 months)
End-to-end remote workflow completion rate
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.
Time frame: From enrollment through study completion (~7 months)
Plan to share: No — 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.
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