Mild Cognitive Impairment (MCI)NCT07594665
Expanding Access to Cognitive Health Biomarker Testing at Home
An observational study of Mild Cognitive Impairment (MCI) and Alzheimer's Dementia (AD), run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Alzheimer's Dementia (AD), Subjective Cognitive Decline (SCD)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2026to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia, School of Nursing
Charlottesville, Virginia, 22908
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment through study completion (~7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start18 May 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan Mattos, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594665
- Sponsor's protocol ID
- IRB-HSR 302986
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Access to Cognitive Health Biomarker Testing at Home
- ClinicalTrials.gov ID
- NCT07594665
- Acronym / sponsor ID
- IRB-HSR 302986
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment (MCI) and Alzheimer's Dementia (AD), run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of remote, at-home p-tau217 workflow (time frame: From enrollment through study completion (~7 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.