Alzheimer DiseaseNCT06622135
Home Test for Measuring Plasma P-tau217 in Alzheimer's Disease
A study testing Tasso Lancet Device in people with Alzheimer Disease and Healthy Subjects, run by Insight Research Institute at 2 sites in United States.
Trial summary
The goal of this is to develop an easy at home test that can be used to assist in diagnosing Alzheimer's disease (AD). The test will use an FDA approved device for at home blood sample collection. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Healthy Subjects
- What is being tested?
- Tasso Lancet Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2024to 7 Dec 2024
- Phase
- Interventional
- 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 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject with Alzheimer's Disease Only: diagnosed according the NIA-AA diagnostic AD criteria
- Healthy Control Only: Subject does not have history of cognitive impairment
- 55 - 90 years old
- Subject able to comply with study procedures
- Subjects must be able to use the Tasso device for blood sample collection as per the provided instructions (can be performed with the assistance of a caregiver)
- Subjects must be able to undergo IV sampling
- Have a study partner who will provide written informed consent to participate, and assist with blood collection when applicable
Who cannot join
- Subjects with systemic conditions which were not adequately controlled through a stable medication regimen
- Subjects with any known significant bleeding disorders or conditions that contraindicate blood sample collection (e.g., hemophilia, severe thrombocytopenia)
- Subjects with a known history of severe skin allergies or reactions to adhesives (since the Tasso device involves adhesive application to the skin)
- Subjects currently taking anticoagulant or antiplatelet medications that could interfere with blood collection or increase the risk of complications
- Subjects who have undergone major surgery or have been hospitalized for any reason in the last 3 months prior to study enrollment
- Participation in a clinical study within the 2 month
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Insight Research Institute/Insight Hospital and Medical Center Chicago
Chicago, Illinois, 60616
Insight Research Institute
Flint, Michigan, 48507
About this study
Official title: Development of a Home Test for Measuring Plasma P-tau217 in Alzheimer's Disease Using Tasso Lancet Device
The goal of this is to develop an easy at home test that can be used to assist in diagnosing Alzheimer's disease (AD). The test will use an FDA approved device for at home blood sample collection. The blood samples will be evaluated to determine if the concentration of p-tau217, a biomarker that is elevated in AD patients, measured from blood samples collected using the at home device is comparable to the results obtained from blood samples collected by venipuncture.
- Conditions
- Alzheimer Disease, Healthy Subjects
- Being tested
- Tasso Lancet Device
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasso Lancet DeviceDevice
blood samples will be obtained from all participants using Tasso device
| Study group | Role | What they receive |
|---|---|---|
| Blood draw using IV and at home device | Other | Not described Receives: Device: Tasso Lancet Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between measurements of P-tau217 concentration in blood samples from Tasso device and venipuncture
Measured: Day 1
Secondary outcomes (5)
Means of p-tau217 concentration in subjects with and without AD
Measured: Day 1
Agreement between measurements of P-tau217 concentration by the ALZpath P-tau217 and Janssen P-tau217+ assays
Measured: Day 1
Percentage of Tasso devices which are loss, damaged, or with inadequate blood volume for analysis
Measured: Day 1
Mean fold-change of p-tau217 concentration in subjects with and without AD
Measured: Day 1
Effect size of p-tau217 concentration in subjects with and without AD
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 posted1 Oct 2024
- Study start19 Sep 2024
- Primary completion7 Dec 2024
- Study completion7 Dec 2024
Why it stopped: Lack of Funding
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insight Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Gharaibeh, Insight Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622135
- Sponsor's protocol ID
- STU24080011
- Status last verified
- Feb 2025
- First submitted
- 19 Sep 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified Data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Home Test for Measuring Plasma P-tau217 in Alzheimer's Disease Using Tasso Lancet Device
- ClinicalTrials.gov ID
- NCT06622135
- Acronym / sponsor ID
- STU24080011
- Conditions
- Alzheimer Disease, Healthy Subjects
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Funding
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Insight Research InstituteUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 7 Dec 2024 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 1 Oct 2024 (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 is to develop an easy at home test that can be used to assist in diagnosing Alzheimer's disease (AD). The test will use an FDA approved device for at home blood sample collection. The blood samples will be evaluated to determine if the concentration of p-tau217, a biomarker that is elevated in AD patients, measured from blood samples collected using the at home device is comparable to the results obtained from blood samples collected by venipuncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood draw using IV and at home device | Other | Device: Tasso Lancet Device |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject with Alzheimer's Disease Only: diagnosed according the NIA-AA diagnostic AD criteria
- Healthy Control Only: Subject does not have history of cognitive impairment
- 55 - 90 years old
- Subject able to comply with study procedures
- Subjects must be able to use the Tasso device for blood sample collection as per the provided instructions (can be performed with the assistance of a caregiver)
Key exclusion criteria (6 listed)
- Subjects with systemic conditions which were not adequately controlled through a stable medication regimen
- Subjects with any known significant bleeding disorders or conditions that contraindicate blood sample collection (e.g., hemophilia, severe thrombocytopenia)
- Subjects with a known history of severe skin allergies or reactions to adhesives (since the Tasso device involves adhesive application to the skin)
- Subjects currently taking anticoagulant or antiplatelet medications that could interfere with blood collection or increase the risk of complications
- Subjects who have undergone major surgery or have been hospitalized for any reason in the last 3 months prior to study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tasso Lancet Deviceblood samples will be obtained from all participants using Tasso device | Device | Blood draw using IV and at home device |
Primary outcome
Agreement between measurements of P-tau217 concentration in blood samples from Tasso device and venipuncture
Time frame: Day 1
5 secondary outcomes
Means of p-tau217 concentration in subjects with and without AD
Time frame: Day 1
Agreement between measurements of P-tau217 concentration by the ALZpath P-tau217 and Janssen P-tau217+ assays
Time frame: Day 1
Percentage of Tasso devices which are loss, damaged, or with inadequate blood volume for analysis
Time frame: Day 1
Mean fold-change of p-tau217 concentration in subjects with and without AD
Time frame: Day 1
Effect size of p-tau217 concentration in subjects with and without AD
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Lack of Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: Yes. Deidentified Data will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tasso Lancet Device in people with Alzheimer Disease and Healthy Subjects, run by Insight Research Institute at 2 sites 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 6 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: stopped early, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Lack of Funding). Results are not available in the source record.
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?
Agreement between measurements of P-tau217 concentration in blood samples from Tasso device and venipuncture (time frame: Day 1). 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 11 Feb 2025.