Using a blood test to detect Alzheimer's in hospitalized older adults with sudden confusion
Clinical Trial Protocol: Alzheimer's Dementia Underlying Encephalopathy
This will test whether the Quest AD-Detect blood test can identify underlying Alzheimer's disease in hospitalized patients aged 60–90 who have new confusion, delirium, or encephalopathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | Covenant Health, US Academic / other |
| Locations | 6 sites (Crossville, Tennessee and 5 other locations) |
| Trial ID | NCT07222280 on ClinicalTrials.gov |
What this trial studies
Hospitalized patients aged 60–90 with an acute cognitive diagnosis such as delirium or encephalopathy will receive the Quest AD-Detect blood test while inpatient. The test result will be used as a risk assessment for underlying Alzheimer's disease to see if it speeds recognition of AD compared with usual care. Neurology providers will perform a 6-month post-hospitalization follow-up to review results and clinical risk. The trial focuses on distinguishing AD-related pathology from other toxic or metabolic causes of cognitive impairment in the inpatient setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 to 90 who are currently hospitalized with new-onset cognitive impairment (for example delirium or encephalopathy) and have no prior diagnosis of dementia.
Not a fit: Patients under 60 or those with a prior diagnosis of a dementing illness or clear alternative organic cause of cognitive impairment are unlikely to benefit from this test in this trial.
Why it matters
Potential benefit: If successful, this approach could lead to earlier identification of Alzheimer's disease in patients hospitalized with sudden cognitive problems, enabling earlier planning and care decisions.
How similar studies have performed: Similar plasma-based biomarker tests for Alzheimer's pathology have shown promise in outpatient settings, but using a blood-based AD test during acute hospitalization is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Crossville, Tennessee and 5 other locations
- Cumberland Medical Center — Crossville, Tennessee, United States (Recruiting)
- Roane Medical Center — Harriman, Tennessee, United States (Recruiting)
- Fort Sanders Regional Medical Center — Knoxville, Tennessee, United States (Recruiting)
- Fort Loudon Medical Center — Lenoir City, Tennessee, United States (Recruiting)
- Methodist Medical Center — Oak Ridge, Tennessee, United States (Recruiting)
- LeConte Medical Center — Sevierville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Samuel Moore, MD — Covenant Health, Canada
- Study coordinator: Clinical Research Nurse Coordinator
- Email: aholt10@covhlth.com
- Phone: 865-331-1337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.