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

Indiana University

Status

Completed

Conditions

Mild Cognitive Impairment

Treatments

Device: PrecivityAD

Study type

Observational

Funder types

Other

Identifiers

NCT05844488

15289

Details and patient eligibility

About

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.

Full description

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.

Enrollment

26 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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