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

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Device: PrecivityAD

• Registration Number: NCT05844488
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-03-31
• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-05-06
• Primary Completion: 2023-05-28
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood based biomarker group	PrecivityAD	Subjects who consent to having a blood based biomarker performed

Primary Outcome Measures

Name	Time	Method
Number of Patients who are willing to have Blood Based Biomarkers Performed	Mar 31, 2023 to May 31, 2023	Evaluate the feasibility and acceptability of implementing blood-based biomarker testing for Alzhiemer's Disease and Related Dementia in primary care practices

Trial Locations

Locations (1)

Indiana University Health Physicians Primary Care; 🇺🇸 Indianapolis, Indiana, United States