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

NCT05844488 | Completed FDA Device

• 1 other identifier: 15289
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Number of Patients who are willing to have Blood Based Biomarkers Performed

  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

Study Arms (1)

Blood based biomarker group

Subjects who consent to having a blood based biomarker performed

Device: PrecivityAD

Interventions

PrecivityAD 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.

Blood based biomarker group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Davos Alzheimer's Collaborative: collaborator
• Regenstrief Institute, Inc.: collaborator

Study Sites (1)

Indiana University Health Physicians Primary Care

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 6, 2023
• Study Start: March 31, 2023
• Primary Completion: May 28, 2023
• Study Completion: June 30, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)