Clinical Trial Protocol: Alzheimer's Dementia Underlying Encephalopathy

NCT07222280 | Recruiting FDA Device

• 1 other identifier: ADUE2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Alzheimer Dementia; Alzheimer Disease; Delirium Confusional State; Encephalopathy; Cognitive Abnormality

Outcome Measures

Primary Outcomes (1)

• 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

  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.

Study Arms (1)

All eligible patients will receive a Quest AD-Detect blood test

OTHER

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

Interventions

Quest AD-Detect blood test DIAGNOSTIC_TEST

Blood will be collected and sent for testing using the Quest AD-Detect blood test

All eligible patients will receive a Quest AD-Detect blood test

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Covenant Health, US: lead

Study Sites (6)

Cumberland Medical Center

Crossville, Tennessee, 38555, United States

RECRUITING

Roane Medical Center

Harriman, Tennessee, 37748, United States

RECRUITING

Fort Sanders Regional Medical Center

Knoxville, Tennessee, 37916, United States

RECRUITING

Fort Loudon Medical Center

Lenoir City, Tennessee, 37772, United States

RECRUITING

Methodist Medical Center

Oak Ridge, Tennessee, 37830, United States

RECRUITING

LeConte Medical Center

Sevierville, Tennessee, 37862, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Confusion; Brain Diseases

Condition Hierarchy (Ancestors)

Dementia; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Moore, MD

  Covenant Health, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Nurse Coordinator

CONTACT

865-331-1337; aholt10@covhlth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: October 29, 2025
• Study Start: June 10, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)