Expanding Access to Cognitive Health Biomarker Testing at Home

NCT07594665 | Enrolling By Invitation

• 1 other identifier: IRB-HSR 302986
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment (MCI); Alzheimer's Dementia (AD); Subjective Cognitive Decline (SCD); Cognitive Aging

Keywords

Phosphorylated tau-217; Blood-based biomarkers; At-home capillary blood collection; Remote/decentralized clinical research; Feasibility; Acceptability; Older adults; Rural and underserved populations; Early detection of Alzheimer's disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment through study completion (~7 months)

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia, School of Nursing

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 19, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)