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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparing the patterns of [18F]NOS brain uptake with patterns of cerebral amyloidosis and neurodegeneration using PET/CT
Brain
Secondary outcome measures
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

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).

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,189 Total Patients Enrolled

Media Library

AD/MCI or HC Clinical Trial Eligibility Overview. Trial Name: NCT04274998 — Phase < 1
Alzheimer's Disease Research Study Groups: AD/MCI or HC, AD/MCI or HC with Genetic Polymorphism
Alzheimer's Disease Clinical Trial 2023: AD/MCI or HC Highlights & Side Effects. Trial Name: NCT04274998 — Phase < 1
AD/MCI or HC 2023 Treatment Timeline for Medical Study. Trial Name: NCT04274998 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant limit for this clinical trial?

"Confirmed. Clinicaltrials.gov reveals that this clinical trial, initially posted on March 3rd 2020, is currently recruiting participants. In total 20 patients need to be enrolled at one medical facility."

Answered by AI

Is enrollment for this trial still open?

"Per the information on clinicaltrials.gov, this trial is actively recruiting participants. The first advertisement was posted March 3rd 2020 and has since been updated as recently as August 17th 2022."

Answered by AI

Who else is applying?

What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Interested in healthy volunteer trials that will help other people especially this one. My grandmother had Alzheimer's.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do screening visits take? Is there any compensation?
PatientReceived 2+ prior treatments
~3 spots leftby Mar 2025