Alzheimer s DiseaseNCT07701161
Development of a Home Test for Measuring Blood P-tau217 in Alzheimer's Disease Using the Tasso Lancet Device
An observational study of Alzheimer s Disease and MCI Conversion to Dementia, run by Neurogen Biomarking LLC at 5 sites in United States.
Trial summary
This study compares p-tau217 concentrations in blood collected via the Tasso device versus standard venipuncture in subjects with and without Alzheimer's disease, including a subset with confirmed amyloid pathology. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer s Disease, MCI Conversion to Dementia, pTau217
- How many people
- 1,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Jan 2025to 1 Aug 2026
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 40-90 recruited through clinical records review, advertising, and community outreach, including AD patients, cognitively healthy controls, and non-AD cognitively impaired individuals with confirmed amyloid-negative status. A subset has amyloid pathology confirmed via PET or CSF.
Who may be able to join
- AD Amyloid PET/CSF confirmed, healthy control, or amyloid-negative non-AD cognitive impairment Age 40-90 Able to complete Tasso and venipuncture collection Caregiver consent/assistance available if needed
Who cannot join
- Uncontrolled systemic conditions Recent surgery/hospitalization (3 months) Other dementia drug trial (2 months) Pregnancy Prior Donanemab or Lecanemab use
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 1 recruiting
- Recruiting
Insigth Hospital and Medical Center Chicago
Chicago, Illinois, 60616
Ansam Eghzawi, MD, +18109410076, ansam@neurogenbiomarking.com
Elisabeth Thijssen, PhD, +16282788161, elisabeth@neurogenbiomarking.com
- Active, not recruiting
Insight Hospital and Medical Center Dearborn
Dearborn, Michigan, 48126
- Active, not recruiting
Insight Institute of Neurology and Neurosurgery
Flint, Michigan, 48507
- Active, not recruiting
Memorial Healthcare Hospital
Owosso, Michigan, 48867
- Active, not recruiting
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
This study compares p-tau217 concentrations in blood collected via the Tasso device versus standard venipuncture in subjects with and without Alzheimer's disease, including a subset with confirmed amyloid pathology.
- Conditions
- Alzheimer s Disease, MCI Conversion to Dementia, pTau217, Biomarkers
- Keywords
- Alzheimer's disease, Neurogen Biomarking, pTau, MCI, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
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 |
|---|---|---|
| AD subjects | Amyloid PET/CSF confirmed and clinically diagnosed | |
| Healthy Controls | No history of cognitive impairment | |
| Non-AD cognitively impaired (amyloid-negative) | Cognitive impairment not due to AD, confirmed amyloid-negative via PET/CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between p-tau217 concentration in Tasso device capillary blood and venipuncture blood
Mean, mean fold-change, and effect size of p-tau217 in Tasso samples between AD and non-AD groups.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start13 Jan 2025
- Primary completion20 Mar 2026
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurogen Biomarking LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rany Aburashed, Principal investigator, Insight Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701161
- Sponsor's protocol ID
- Neurogen-12951
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Home Test for Measuring Blood P-tau217 in Alzheimer's Disease Using the Tasso Lancet Device
- ClinicalTrials.gov ID
- NCT07701161
- Acronym / sponsor ID
- Neurogen-12951
- Conditions
- Alzheimer s Disease, MCI Conversion to Dementia, pTau217, Biomarkers
- Keywords
- Alzheimer's disease, Neurogen Biomarking, pTau, MCI, Dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Neurogen Biomarking LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 14 Jul 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.
This study compares p-tau217 concentrations in blood collected via the Tasso device versus standard venipuncture in subjects with and without Alzheimer's disease, including a subset with confirmed amyloid pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AD subjects | – | –Amyloid PET/CSF confirmed and clinically diagnosed |
| Healthy Controls | – | –No history of cognitive impairment |
| Non-AD cognitively impaired (amyloid-negative) | – | –Cognitive impairment not due to AD, confirmed amyloid-negative via PET/CSF |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40-90 recruited through clinical records review, advertising, and community outreach, including AD patients, cognitively healthy controls, and non-AD cognitively impaired individuals with confirmed amyloid-negative status. A subset has amyloid pathology confirmed via PET or CSF.
Key inclusion criteria (1 listed)
- AD Amyloid PET/CSF confirmed, healthy control, or amyloid-negative non-AD cognitive impairment Age 40-90 Able to complete Tasso and venipuncture collection Caregiver consent/assistance available if needed
Key exclusion criteria (1 listed)
- Uncontrolled systemic conditions Recent surgery/hospitalization (3 months) Other dementia drug trial (2 months) Pregnancy Prior Donanemab or Lecanemab use
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
Agreement between p-tau217 concentration in Tasso device capillary blood and venipuncture blood
Time frame: Baseline
Mean, mean fold-change, and effect size of p-tau217 in Tasso samples between AD and non-AD groups.
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 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Alzheimer s Disease
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.
Rany Aburashed principal investigator
Insight Health Systems
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer s Disease and MCI Conversion to Dementia, run by Neurogen Biomarking LLC at 5 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 1 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
Contact Ansam Eghzawi, MD (+18109410076, ansam@neurogenbiomarking.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between p-tau217 concentration in Tasso device capillary blood and venipuncture blood (time frame: Baseline). 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 14 Jul 2026.