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| Name | Class |
|---|---|
| Davos Alzheimer's Collaborative | UNKNOWN |
| Regenstrief Institute, Inc. | OTHER |
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The primary objective of this study is to evaluate the feasibility of implementing blood-based biomarker testing for amyloid positivity designed to aid the early detection of Alzheimer's Disease and Related Dementia (ADRD) in patients 65+ including the rate that patients and providers follow up abnormal blood-based biomarker testing.
This study is conducted to evaluate whether a new approach to screening patients for cognitive decline in primary care practices helps with earlier detection of Alzheimer's Disease. As part of the study, the provider subjects will receive training about the PrecivityAD blood biomarker test offered by C2N Diagnostics. They will be able to order the PrecivityAD test for possible Alzheimer's disease if their patient has an abnormal screening for cognitive impairment and consents to this study. Patient subjects will have their blood drawn (1 teaspoon) for the PrecivityAD blood test and will be asked to complete a surveys before and after the blood drawn. They will receive follow up phone calls within 1 to 4 weeks after they discuss the results of their blood test with their primary care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood based biomarker group | Subjects who consent to having a blood based biomarker performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrecivityAD | Device | Measure risk for amyloid plaques in the brain and will include a test for certain genetic variants (specifically, ApoE proteins in the blood revealing APOE genotype) known to be associated with Alzheimer's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients who are willing to have Blood Based Biomarkers Performed | Evaluate the feasibility and acceptability of implementing blood-based biomarker testing for Alzhiemer's Disease and Related Dementia in primary care practices | Mar 31, 2023 to May 31, 2023 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Physicians Primary Care | Indianapolis | Indiana | 46202 | United States |
Identifiable individual participant data will not be shared with other researchers.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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