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

NCT07187921 | Completed

• 2 other identifiers: API-003R01AG058468
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

plasma pTau217

Outcome Measures

Primary Outcomes (4)

• Assess the accuracy of within-participant plasma pTau-217 testing on separated blood collected via finger prick with the Capitainer SEP10 single channel device in comparison to venipuncture-based collected samples.

  compare pTau-217 assay value from finger prick blood sample to assay value from previously collected venipuncture-based collected blood

  Day 1

• Characterize the feasibility of finger prick blood collection with the Capitainer SEP10 single channel device.

  participant survey

  Day 1

• Characterize the tolerability of finger prick blood collection with the Capitainer SEP10 single channel device.

  participant survey

  Day 1

• Characterize the acceptability of finger prick blood collection with the Capitainer SEP10 single channel device.

  participant survey

  Day 1

Secondary Outcomes (1)

• Analyze any differences in biomarker level from the finger prick blood samples collected via finger prick with the Capitainer SEP10 single channel device in comparison to venipuncture-based collected samples.

  Day 1

Study Arms (1)

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

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Draw-10 study participants at Banner Alzheimer's Institute-Phoenix

You may qualify if:

• 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.

Sponsors & Collaborators

• Banner Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

dried blood spot cards

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Jessica B Langbaum, PhD

  Banner Alzheimer's Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 23, 2025
• Study Start: September 29, 2025
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be shared within 12 months after study completion

Locations

US (1)