F-18 Flornaptitril-PET for Mild Cognitive Impairment
This study is testing a new imaging method called [F-18]Flornaptitril-PET (F-18 FNT-PET) to see how well it can predict if someone with Mild Cognitive Impairment (MCI) will get worse over time. MCI can be due to suspected Chronic Traumatic Encephalopathy (CTE) or Alzheimer's Disease (AD). All participants will receive a single dose of F-18 FNT during an imaging visit. Researchers will also check the safety of F-18 FNT. The study aims to enroll 230 participants aged 45 and older who have MCI and a trial partner. The study's current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment or intervention. It aims to enroll 230 participants.
- What's involved
- Participants will receive a single dose of F-18 FNT during an imaging visit. Safety will be assessed using adverse events, serious adverse events, and vital signs.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for two years to assess clinical decline and the safety of F-18 FNT.
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Visualizing Brain Proteinopathies Using [F-18]Flornaptitril-PET in the Prediction of Clinical Progression of Mild Cognitive Impairment With Either Suspected Chronic Traumatic Encephalopathy or Alzheimer's Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Chad Yucus, MD · PRINCIPAL_INVESTIGATOR · Endeavor Health System
Who to contact
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What this trial measures
- Accuracy of F-18 FNT-PET in prediction of clinical decline2 years
The correlation between predictive development of neurodegeneration as made from F-18 FNT-PET and score change from baseline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at the 2-year Follow-up Visit
- Assessment of the safety of F-18 FNT using adverse events and serious adverse events.2 years
Adverse events and serious adverse events will be monitored in patients following F-18 FNT administration.
- Assessment of the safety of F-18 FNT using vital signs.2 years
A patients body temperature, respiratory rate, sitting radial pulse rate, and sitting systolic and diastolic blood pressures will be monitored in patients following F-18 FNT administration.
- Assessment of the safety of F-18 FNT using clinical laboratory assessments.2 years
A patients complete blood count with differential, free T4 Index, Vitamin B12 serum, chemistry panel (glucose, calcium, sodium, potassium, carbon dioxide, chlorine, albumin and total protein, ALP, ALT, AST, bilirubin, BUN, creatinine), benzodiazepines, uric acid, thyroid-stimulating hormone, and cholesterol will be monitored in patients following F-18 FNT administration.
- Assessment of the safety of F-18 FNT using electrocardiograms2 years
12-Lead electrocardiograms (ECGs) will be performed for all participants at Screening and in-person Follow-up Visit(s). Triplicate 12-lead ECG measurements will be obtained approximately 2 minutes apart. A repeat 12-lead ECG recording may be obtained to confirm ECG findings at the discretion of the Investigator. A full assessment of the ECG will be performed including P Wave, QRS Complex, and QT Interval.
- Assessment of the safety of F-18 FNT using the Suicide Behavior Questionnaire-Revised2 years
The Suicide Behavior Questionnaire-Revised will be given and assessed in patients following F-18 FNT administration.