Alzheimer DementiaNCT07222280
Clinical Trial Protocol: Alzheimer's Dementia Underlying Encephalopathy
A study testing Quest AD-Detect blood test in people with Alzheimer Dementia and Alzheimer Disease, run by Covenant Health, US at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer Dementia, Alzheimer Disease, Delirium Confusional State
- What is being tested?
- Quest AD-Detect blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- 10 Jun 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age under 60 years
- Prior diagnosis of dementing illness or other organic etiology to cognitive impairment
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Cumberland Medical Center
Crossville, Tennessee, 38555
Clinical Research Nurse Coordinator, 865-331-1337, aholt10@covhlth.com
Samuel A. Moore, MD
- Recruiting
Roane Medical Center
Harriman, Tennessee, 37748
Clinical Research Nurse Coordinator, 865-331-1337, aholt10@covhlth.com
Samuel A. Moore, MD
- Recruiting
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916
Clinical Research Nurse Coordinator, 865-331-1337, aholt10@covhlth.com
Samuel A. Moore, MD
- Recruiting
Fort Loudon Medical Center
Lenoir City, Tennessee, 37772
Clinical Research Nurse Coordinator, 865-331-1337, aholt10@covhlth.com
Samuel A. Moore, MD
- Recruiting
Methodist Medical Center
Oak Ridge, Tennessee, 37830
Clinical Research Nurse Coordinator, 865-331-1337, aholt10@covhlth.com
Samuel A. Moore, MD
- Recruiting
LeConte Medical Center
Sevierville, Tennessee, 37862
Clinical Research Nurse Coordinator, 865-331-1337, aholt10@covhlth.com
Samuel A. Moore, MD
About this study
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
- Being tested
- Quest AD-Detect blood test
- Medical subject headings
- Alzheimer Disease, Confusion, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quest AD-Detect blood testDiagnostic test
Blood will be collected and sent for testing using the Quest AD-Detect blood test
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Quest AD-Detect blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to 6 month follow up appointment with Neurology Clinic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start10 Jun 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Covenant Health, US
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Moore, MD, Principal investigator, Covenant Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222280
- Sponsor's protocol ID
- ADUE2025
- Status last verified
- Oct 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Protocol: Alzheimer's Dementia Underlying Encephalopathy
- ClinicalTrials.gov ID
- NCT07222280
- Acronym / sponsor ID
- ADUE2025
- Conditions
- Alzheimer Dementia, Alzheimer Disease, Delirium Confusional State, Encephalopathy, Cognitive Abnormality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Covenant Health, USUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All eligible patients will receive a Quest AD-Detect blood test | Other | Diagnostic Test: Quest AD-Detect blood testAll patients that meet the inclusion criteria, and none of the exclusion criteria, will have their blood tested with the Quest AD-Detect |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age under 60 years
- Prior diagnosis of dementing illness or other organic etiology to cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quest AD-Detect blood testBlood will be collected and sent for testing using the Quest AD-Detect blood test | Diagnostic test | All eligible patients will receive a Quest AD-Detect blood test |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel Moore, MD principal investigator
Covenant Health, Canada
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quest AD-Detect blood test in people with Alzheimer Dementia and Alzheimer Disease, run by Covenant Health, US at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Nurse Coordinator (865-331-1337, aholt10@covhlth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.