NCT04274998Active, not recruitingEarly phase 1
Neuroinflammation Imaging in AD
Evaluation of in Vivo Neuroinflammation in Alzheimer's Disease Using Novel Positron Emission Tomography (PET/CT) Imaging
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
This research study is being done to learn more about inflammation in the brain using Positron Emission Tomography/Computed Tomography (PET/CT) imaging in people with Alzheimer's Disease/Mild Cognitive Impairment or healthy controls. If the subject agrees to be in this study, she/ he will have a PET/CT scan using the investigational radiotracer \[18F\]NOS. A subject with a specific genetic polymorphism may also agree to be in the sub-study in which she/he will have another PET/CT scan using the investigational tracer \[11C\]PBR28 for comparison with the FNOS \[18F\]NOS scan. For subjects who agree to this sub-study they may undergo the brain PET/CT scan with \[11C\]PBR28 either on the same day as the \[18F\]NOS PET/CT or on another day. The subject may have a screening visit before the PET/CT scan visit if the investigator needs to confirm the subject is able to be in the study. A blood sample will be taken before the scans. Additional blood samples will be taken during the PET scans. Subjects must also agree to have an MRI scan for this research study if she/he has not had a recent scan that the study doctor decides can be used for this study.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 12 Feb 2020
- Start date
- 3 Mar 2020
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- University of Pennsylvania
- Diseases
- Alzheimer disease
- NCT number
- NCT04274998
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 9
- From 3 Mar 2020 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of epilepsy or seizure disorder as assessed by medical record review and/or self-report
- History of head trauma or evidence of structural abnormalities such as a major stroke or mass on MRI that in the opinion of an investigator may interfere with the uptake of applicable radiotracer as assessed by medical record review and/or self-report
- Current tobacco or nicotine dependence. History of greater than 5 pack years of smoking and less than 2 years since smoking cessation.
- Have a history of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study
Other
- Females of child-bearing potential will not be included, female subjects must be post-menopausal or surgically sterile
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
Who the study is looking for
- \- Males and females ≥ 55 years of age
- Part of the UPenn ADC research cohort with designation of cognitively normal per ADC database.
- A brain amyloid PET scan ≤ 1 year prior to enrollment in this study that is determined to be negative by the study PI.
- Mini-mental status exam (MMSE) score of 28 or higher per ADC database.
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
- Males and females ≥ 55 years of age
- Part of the Upenn ADC research cohort with designation that the presence of Alzheimer's pathology is likely per ADC database.
- A brain amyloid PET scan ≤ 1 year prior to enrollment in this study that is determined to be positive by the study PI.
- Mini-mental status exam (MMSE) score of 14-27 per ADC database.
- Subjects must have a designated study partner to accompany them to study visits
- 1\. High affinity carrier of the rs6971 TSPO polymorphism (whole genome sequencing is available from the UPenn ADC research cohort and will be interrogated for this polymorphism)
Age in the registry: 55 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.