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Neuroinflammation Imaging for Alzheimer's Disease

Phase < 1

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females ≥ 55 years of age

- Males and females ≥ 55 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is being done to learn more about inflammation in the brain using PET/CT imaging in people with Alzheimer's Disease/Mild Cognitive Impairment or healthy controls.

Who is the study for?

This trial is for men and women over 55, either healthy or with Alzheimer's/Mild Cognitive Impairment. Healthy participants need a negative amyloid PET scan and an MMSE score of 28+. Those with Alzheimer's should have a positive amyloid PET scan and an MMSE score of 14-27. All must be part of the UPenn ADC cohort, informed about the study's nature, consent in writing, and follow guidelines.

What is being tested?

The study tests two brain imaging agents ([18F]NOS and [11C]PBR28) using PET/CT scans to understand brain inflammation in Alzheimer’s Disease/Mild Cognitive Impairment versus healthy subjects. Some may also join a sub-study comparing both tracers. Participants will undergo blood tests and possibly an MRI.

What are the potential side effects?

Potential side effects are not detailed here but could include reactions related to the injection site from radiotracers used during PET/CT scans or discomforts associated with blood sampling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 55 years old or older.

Select...

I am 55 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparing the patterns of [18F]NOS brain uptake with patterns of cerebral amyloidosis and neurodegeneration using PET/CT

Brain

Secondary study objectives

Comparing the patterns of [11C]PBR28 brain uptake with patterns of cerebral amyloidosis and neurodegeneration using PET/CT

Understanding the uptake of [11C]PBR28 in the human brain in AD/MCI and Healthy Controls with a specific genetic polymorphism

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: AD/MCI or HC with Genetic PolymorphismExperimental Treatment1 Intervention

Sub-Study: Subjects have a specific genetic polymorphism andare diagnosed with Alzheimer's Disease (AD)/Mild Cognitive Imparment (MCI) or are healthy volunteers/controls (HC).

Group II: AD/MCI or HCExperimental Treatment1 Intervention

Main Study: Subjects are diagnosed with Alzheimer's Disease (AD)/Mild Cognitive Imparment (MCI) or are healthy volunteers/controls (HC).

0 / 2Eligibility criteria met