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

Sponsor

Indiana University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05844488

Collaborator

Davos Alzheimer's Collaborative (Other), Regenstrief Institute, Inc. (Other)

600

Enrollment

Location

Anticipated Duration (Months)

200.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Device: PrecivityAD

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 Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

DIGITAL Biomarker: Blood Based Biomarkers in the Primary Care Setting for Timely and Accurate Diagnosis of Alzheimer's Disease

Actual Study Start Date :

Mar 31, 2023

Anticipated Primary Completion Date :

May 28, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Blood based biomarker group Subjects who consent to having a blood based biomarker performed	Device: 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.

Arm

Intervention/Treatment

Blood based biomarker group

Subjects who consent to having a blood based biomarker performed

Device: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Health Physicians Primary Care	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Indiana University
Davos Alzheimer's Collaborative
Regenstrief Institute, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Deanna Willis, Principal Investigator, Indiana University

ClinicalTrials.gov Identifier:

NCT05844488

Other Study ID Numbers:

15289

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Alzheimer Disease

Cognitive Dysfunction

Study Results

No Results Posted as of May 6, 2023