Expanding Access to Cognitive Health Biomarker Testing at Home

N/AEnrolling By InvitationNCT07594665

University of Virginia100 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.