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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ansam Eghzawi, MD | Contact | +18109410076 | ansam@neurogenbiomarking.com | |
| Elisabeth Thijssen, PhD | Contact | +16282788161 | elisabeth@neurogenbiomarking.com |
| Name | Affiliation | Role |
|---|---|---|
| Rany Aburashed | Insight Health Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insigth Hospital and Medical Center Chicago | Recruiting | Chicago | Illinois | 60616 | United States |
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Plasma and serum from venipuncture and Tasso device capillary blood samples; dried blood spot (DBS) cards from a subset of participants. Samples are stored at -80°C (plasma/serum) or room temperature in desiccant-containing pouches (DBS), and may be used for future p-tau217 assay development and validation activities.
| Insight Hospital and Medical Center Dearborn | Active, not recruiting | Dearborn | Michigan | 48126 | United States |
| Insight Institute of Neurology and Neurosurgery | Active, not recruiting | Flint | Michigan | 48507 | United States |
| Memorial Healthcare Hospital | Active, not recruiting | Owosso | Michigan | 48867 | United States |
| Wake Forest Baptist Medical Center | Active, not recruiting | Winston-Salem | North Carolina | 27157 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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