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New imaging method could reveal hidden inflammation in Alzheimer's brains
NCT ID NCT04274998
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study uses special PET scans to look for signs of inflammation in the brains of people with Alzheimer's disease or mild cognitive impairment, compared to healthy volunteers. Nine participants will receive an investigational radioactive tracer called [18F]NOS, and some may also get a second tracer, [11C]PBR28, for comparison. The goal is to see whether these scans can detect inflammation and how it relates to other Alzheimer's brain changes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [18F]NOS and [11C]PBR28 (investigational radiotracers for PET imaging)
- What this could lead to
- If successful, this could help researchers better understand how inflammation relates to Alzheimer's disease, potentially guiding future treatments.
- What could go wrong
- This is a very small, early-phase imaging study with only 9 participants, so results may not apply broadly. The tracers are investigational and not yet proven to be useful in routine care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
9 people
The number who actually took part.
- Started
-
Mar 2020
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (HC cohort only): 1. \- Males and females ≥ 55 years of age 2. Part of the UPenn ADC research cohort with designation of cognitively normal per ADC database. 3. A brain amyloid PET scan ≤ 1 year prior to enrollment in this study that is determined to be negative by the study PI. 4. Mini-mental status exam (MMSE) score of 28 or higher per ADC database. 5. 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. Inclusion Criteria (AD/MCI cohort only) 1. Males and females ≥ 55 years of age 2. Part of the Upenn ADC research cohort with designation that the presence of Alzheimer's pathology is likely per ADC database. 3. A brain amyloid PET scan ≤ 1 year prior to enrollment in this study that is determined to be positive by the study PI. 4. Mini-mental status exam (MMSE) score of 14-27 per ADC database. 5. Subjects must have a designated study partner to accompany them to study visits Inclusion Criteria 11C-PBR28 sub-study (both HC and AD/MCI cohorts) 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) Exclusion Criteria (HC and PD cohorts): 1. Females of child-bearing potential will not be included, female subjects must be post-menopausal or surgically sterile 2. History of epilepsy or seizure disorder as assessed by medical record review and/or self-report 3. 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 4. Current tobacco or nicotine dependence. History of greater than 5 pack years of smoking and less than 2 years since smoking cessation. 5. Have a history of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported 6. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 7. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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