DIGITAL Biomarker: Blood Based Biomarkers in the Primary Care Setting for Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood based biomarker group

Subjects who consent to having a blood based biomarker performed

PrecivityAD

Intervention Type 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.

Interventions

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PrecivityAD

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients must be \> 65 years of age
* Any gender
* Is an established or new patient at one of the 6 participating IUHP PC sites
* Is able to provide informed consent (research portion only for the biomarker consent) or has a Legally Authorized Representative (LAR) who can provide informed consent
* Has a "red" DCA screening in the last 12 months (a score of 0 or 1 out of 5)

Exclusion Criteria

* Patients who do not complete a DCA screening for any reason
* Existing diagnosis of dementia documented in their medical record based on ICD-10 codes

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No