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Clinical Trials/NCT07222280
NCT07222280RecruitingNot Applicable

Clinical Trial Protocol: Alzheimer's Dementia Underlying Encephalopathy

Covenant Health, US6 sites in 1 country30 target enrollmentStarted: June 10, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
30
Locations
6
Primary Endpoint
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

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
60 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: Quest AD-Detect blood test (Diagnostic Test)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Covenant Health, US
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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