Clinical Trial Protocol: Alzheimer's Dementia Underlying Encephalopathy

October 27, 2025 updated by: Covenant Health, US

The goal of this clinical trial is to determine if utilizing the Quest AD-Detect blood test, while patient's are hospitalized for a cognitive diagnosis (such as delirium or encephalopathy), will result in an earlier diagnosis of underlying Alzheimer's disease.

  • Will this blood test have the ability to distinguish between Alzheimer's disease and other causes of cognitive impairment in the inpatient setting?
  • Neurology Clinic will complete a 6-month post-hospitalization follow up with patients who have had the Quest AD-Detect Alzheimer's Disease blood test completed while they were inpatient to discuss the risk assessment portfolio

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Clinical Research Nurse Coordinator
  • Phone Number: 865-331-1337
  • Email: aholt10@covhlth.com

Study Locations

  • United States
    • Tennessee
      • Crossville, Tennessee, United States, 38555
        • Recruiting
        • Cumberland Medical Center
        • Contact:
        • Principal Investigator:
          • Samuel A. Moore, MD
      • Harriman, Tennessee, United States, 37748
        • Recruiting
        • Roane Medical Center
        • Contact:
        • Principal Investigator:
          • Samuel A. Moore, MD
      • Knoxville, Tennessee, United States, 37916
        • Recruiting
        • Fort Sanders Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Samuel A. Moore, MD
      • Lenoir City, Tennessee, United States, 37772
        • Recruiting
        • Fort Loudon Medical Center
        • Contact:
        • Principal Investigator:
          • Samuel A. Moore, MD
      • Oak Ridge, Tennessee, United States, 37830
        • Recruiting
        • Methodist Medical Center
        • Contact:
        • Principal Investigator:
          • Samuel A. Moore, MD
      • Sevierville, Tennessee, United States, 37862
        • Recruiting
        • LeConte Medical Center
        • Contact:
        • Principal Investigator:
          • Samuel A. Moore, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ages 60 to 90 years old
  • No prior diagnosis of dementia
  • Currently hospitalized with cognitive diagnosis, including but no limited to; delirium, encephalopathy, etc. thought to be secondary to a toxic/metabolic state

Exclusion Criteria:

  • Age under 60 years
  • Prior diagnosis of dementing illness or other organic etiology to cognitive impairment

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All eligible patients will receive a Quest AD-Detect blood test
All patients that meet the inclusion criteria, and none of the exclusion criteria, will have their blood tested with the Quest AD-Detect
Diagnostic test: Quest AD-Detect blood test
Blood will be collected and sent for testing using the Quest AD-Detect blood test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To show the percentage of patients (21 patients in the study) who presented with a cognitive diagnosis (including but not limited to delirium, encephalopathy, etc.) that have a positive biomarker for Alzheimer's dementia
Time Frame: From enrollment to 6 month follow up appointment with Neurology Clinic.
A Six month follow up with the Neurology clinic to discuss the results of Quest AD Detect (p-tau217), those patients who are found to have a positive outcome will receive additional follow-up in the Neurology clinic (which could include the use of additional lab tests or further diagnostic testing).
From enrollment to 6 month follow up appointment with Neurology Clinic.

Collaborators and Investigators

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

Sponsor

Covenant Health, US

Investigators

  • Principal Investigator: Samuel Moore, MD, Covenant Health, Canada

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)

June 10, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

July 21, 2025

First Submitted That Met QC Criteria

October 27, 2025

First Posted (Estimated)

October 29, 2025

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 27, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADUE2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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