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

July 21, 2023 updated by: Deanna Willis, Indiana University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Physicians Primary Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients who are willing to have Blood Based Biomarkers Performed
Time Frame: 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
Mar 31, 2023 to May 31, 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Regenstrief Institute, Inc.
Davos Alzheimer's Collaborative

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2023

Primary Completion (Actual)

May 28, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Identifiable individual participant data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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