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Lack of Funding
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood draw using IV and at home device | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasso Lancet Device | Device | blood samples will be obtained from all participants using Tasso device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement between measurements of P-tau217 concentration in blood samples from Tasso device and venipuncture | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Means of p-tau217 concentration in subjects with and without AD | Day 1 | |
| Agreement between measurements of P-tau217 concentration by the ALZpath P-tau217 and Janssen P-tau217+ assays | Day 1 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insight Research Institute/Insight Hospital and Medical Center Chicago | Chicago | Illinois | 60616 | United States | ||
Deidentified Data will be shared
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Percentage of Tasso devices which are loss, damaged, or with inadequate blood volume for analysis |
| Day 1 |
| Mean fold-change of p-tau217 concentration in subjects with and without AD | Day 1 |
| Effect size of p-tau217 concentration in subjects with and without AD | Day 1 |
| Insight Research Institute |
| Flint |
| Michigan |
| 48507 |
| United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |