Alzheimer DiseaseeDROP-ADNCT07187921
Evaluation of a Finger Prick Collection Method for Measuring Alzheimer's Disease Blood Biomarkers
An observational study of Alzheimer Disease, run by Banner Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to 12 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Draw-10 study participants at Banner Alzheimer's Institute-Phoenix
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
About this study
Official title: Evaluation of a Finger Prick Collection Method for Measuring Alzheimer's Disease Blood Biomarkers (eDROP-AD)
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.
Read the 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
- Keywords
- plasma pTau217
- Medical subject headings
- 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 |
|---|---|---|
| Participants who enrolled in Draw-10 and provided a venous blood sample | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Characterize the feasibility of finger prick blood collection with the Capitainer SEP10 single channel device.
participant survey
Measured: Day 1
Characterize the tolerability of finger prick blood collection with the Capitainer SEP10 single channel device.
participant survey
Measured: Day 1
Characterize the acceptability of finger prick blood collection with the Capitainer SEP10 single channel device.
participant survey
Measured: 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.
compare assay value from finger prick blood sample to assay value from previously collected venipuncture-based collected blood
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start29 Sep 2025
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banner Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jessica B Langbaum, PhD, Principal investigator, Banner Alzheimer's Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187921
- Sponsor's protocol ID
- API-003
- Other IDs
- R01AG058468
- Acronym
- eDROP-AD
- Status last verified
- Dec 2025
- First submitted
- 11 Sep 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study dataset will be shared with qualified investigators
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Finger Prick Collection Method for Measuring Alzheimer's Disease Blood Biomarkers (eDROP-AD)
- ClinicalTrials.gov ID
- NCT07187921
- Acronym / sponsor ID
- eDROP-AD / API-003
- Conditions
- Alzheimer Disease
- Keywords
- plasma pTau217
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Banner HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 23 Sep 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants who enrolled in Draw-10 and provided a venous blood sample | – | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Draw-10 study participants at Banner Alzheimer's Institute-Phoenix
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -
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
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.
Time frame: Day 1
compare pTau-217 assay value from finger prick blood sample to assay value from previously collected venipuncture-based collected blood
Characterize the feasibility of finger prick blood collection with the Capitainer SEP10 single channel device.
Time frame: Day 1
participant survey
Characterize the tolerability of finger prick blood collection with the Capitainer SEP10 single channel device.
Time frame: Day 1
participant survey
Characterize the acceptability of finger prick blood collection with the Capitainer SEP10 single channel device.
Time frame: Day 1
participant survey
1 secondary outcome
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.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Yes. study dataset will be shared with qualified investigators
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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. This study is not recruiting at the moment.
Jessica B Langbaum, PhD principal investigator
Banner Alzheimer's Institute
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 Alzheimer Disease, run by Banner Health 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 9 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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. (time frame: Day 1). The study lists 4 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 9 Dec 2025.