Evaluation of a Finger Prick Collection Method for Measuring Alzheimer's Disease Blood Biomarkers

NCT ID: NCT07187921

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-29
• Study Completion Date: 2025-11-12

Brief Summary

This is an observational study that will collect blood from a finger prick (Capitainer SEP10 single channel device) and assess the accuracy of pTau-217 testing in comparison to previously collected venous blood samples from the same individuals.

Detailed Description

Blood biomarkers offer a less invasive and cheaper method for identifying Alzheimer's disease (AD)-related pathophysiological changes. AD blood biomarkers are already being adopted by clinical practice and their use will only expand in coming years as access to AD modifying therapies increases. In addition, blood biomarkers are emerging as critical tools in AD research as they allow for streamlined identification of participants with the most relevant underlying levels of AD pathophysiology.

While blood tests offer a less invasive alternative to traditional detection methods (e.g., lumbar puncture, brain imaging), measuring biomarkers through venous blood draws can be logistically challenging, especially in resource-limited areas or for individuals unable to access specialized facilities. The use of blood collection cards could simplify the process, reduce the resources required, and make testing more accessible to a broader population. However, the accuracy of the measurement and their usability and tolerability to patients and research participants is not yet known. This study aims to evaluate acceptability of sampling using finger prick collection with a blood collection card for measuring pTau-217 as well as compare result accuracy to venous blood draw collection, thus addressing accessibility and scalability challenges in AD biomarker testing.

eDROP-AD is an ancillary study of the "Weekly blood draw study to understand the biological variability of plasma pTau-217" (Draw-10). Draw-10 is enrolling approximately 100 adults ages 50-80. Participants come to a study site weekly over a nine-week period for a venous blood draw with a phlebotomist. Participants at a select study site who provide a venous blood draw sample in Draw-10 will be invited to participate in eDROP-AD, leveraging the opportunity to evaluate the participant experience using blood collection cards and compare the results of the venous blood draw samples with blood samples acquired via the Capitainer SEP10 single channel device.

Conditions

Alzheimer Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Participants who enrolled in Draw-10 and provided a venous blood sample

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Able and willing to provide informed consent for the eDROP-AD study.
• Enrolled in the Draw-10 study at Banner Alzheimer's Institute-Phoenix and provided at least one venous blood sample.
• Able and willing to fully comply with study procedures defined in this protocol.
• Written and spoken fluency in the English language.

Exclusion Criteria

-

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Banner Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica B Langbaum, PhD

Role: PRINCIPAL_INVESTIGATOR

Banner Alzheimer's Institute

Locations

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

R01AG058468

Identifier Type: NIH

Identifier Source: secondary_id

View Link

API-003

Identifier Type: -

Identifier Source: org_study_id