Clinical Trial Protocol: Alzheimer's Dementia Underlying Encephalopathy

NCT ID: NCT07222280

Last Updated: 2025-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-10

Study Completion Date

2026-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Alzheimer Dementia Alzheimer Disease Delirium Confusional State Encephalopathy Cognitive Abnormality

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Quest AD-Detect blood test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Quest AD-Detect blood test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Covenant Health, US

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Covenant Health, Canada

Locations

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Cumberland Medical Center

Crossville, Tennessee, United States

Site Status RECRUITING

Roane Medical Center

Harriman, Tennessee, United States

Site Status RECRUITING

Fort Sanders Regional Medical Center

Knoxville, Tennessee, United States

Site Status RECRUITING

Fort Loudon Medical Center

Lenoir City, Tennessee, United States

Site Status RECRUITING

Methodist Medical Center

Oak Ridge, Tennessee, United States

Site Status RECRUITING

LeConte Medical Center

Sevierville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Research Nurse Coordinator

Role: CONTACT

865-331-1337

Facility Contacts

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Clinical Research Nurse Coordinator

Role: primary

865-331-1337

Clinical Research Nurse Coordinator

Role: primary

865-331-1337

Clinical Research Nurse Coordinator

Role: primary

865-331-1337

Clinical Research Nurse Coordinator

Role: primary

865-331-1337

Clinical Research Nurse Coordinator

Role: primary

865-331-1337

Clinical Research Nurse Coordinator

Role: primary

865-331-1337

Other Identifiers

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ADUE2025

Identifier Type: -

Identifier Source: org_study_id

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