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Neuroinflammation Imaging for Alzheimer's Disease
Phase 2
Waitlist Available
Led By Val Lowe, MD
Research Sponsored by Val Lowe
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males or females 60 years of age or older
Capacity to sign consent or have a legally authorized representative to sign the consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 year
Awards & highlights
Study Summary
This trial is testing whether PET/CT imaging can show brain inflammation, and if so, how it relates to Alzheimer's Disease. They're also testing the safety of a new radioactive tracer.
Who is the study for?
This trial is for men and women over 60 who are part of a cognitive study group, have had recent brain scans, and can consent to the study. Pregnant or breastfeeding women, those unable to lie still for scans, on daily anti-inflammatory meds, with generalized inflammation or metal in their body that affects MRI safety cannot join.Check my eligibility
What is being tested?
Researchers are testing a new radioactive tracer called C-11 ER176 using PET/CT imaging to measure brain inflammation related to Alzheimer's Disease. They want to see if this method can help understand the disease better.See study design
What are the potential side effects?
Potential side effects may include reactions from the radiotracer C-11 ER176 used during PET/CT imaging but specific side effects are being studied as part of this research.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Select...
I can sign the consent myself or have someone legally allowed to do it for me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine if neuroinflammation, as measured by C-11 ER176 SUVr and inflammatory blood test measurements, is correlated with an increase in AB plaque, as measured by C-11 PiB SUVr.
Determine if neuroinflammation, as measured by C-11 ER176 SUVr, is correlated with a history of increased cognitive decline in the 5 years preceding PET imaging, as measured by z scores from neuropsychiatric test results (memory, etc.).
Determine if neuroinflammation, as measured by PET imaging, is associated with plasma biomarkers of inflammation.
Secondary outcome measures
Incidence of adverse events attributable to ER176.
Trial Design
1Treatment groups
Experimental Treatment
Group I: C-11 ER176 PET/CTExperimental Treatment2 Interventions
C-11 ER176 is an investigational radiopharmaceutical that will be produced under cGMP in the Mayo Clinic Cyclotron Facility. The imaging agent (C-11 ER176) will be administered on an outpatient basis. It will be administered at a single time IV prior to the PET imaging.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Test
2010
N/A
~320
Find a Location
Who is running the clinical trial?
Val LoweLead Sponsor
Val Lowe, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
116 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to be in one of the four groups (CU A-, CU A+, MCI A+, AD A+).I am not pregnant and can stop breastfeeding for 24 hours.I cannot stay still lying down for 20 minutes.I have been undergoing cognitive tests for at least 3 years.I can sign the consent myself or have someone legally allowed to do it for me.I am 60 years old or older.I take daily anti-inflammatory medication.I haven't taken immunosuppressives or steroids in the last 2 weeks.You cannot have any metal objects or a pacemaker in your body because the study uses MRI scans to compare with PET data.I have had an amyloid PET scan and MRI of my brain in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: C-11 ER176 PET/CT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the odds of negative side effects from this treatment?
"At Power, we give this treatment a safety score of 2. That's because, although Phase 2 trials collect data on safety, there is no existing evidence that the intervention is effective."
Answered by AI
Which patients would be the most ideal candidates for this research?
"Alzheimer's patients aged 60 to 90 who have been cognitively tested for at least 3 years are encouraged to apply for this study. 100 participants will be admitted on a first-come, first-served basis."
Answered by AI
Is this research project only available to those under the age of 60?
"This study's requirements for eligibility include being aged 60-90."
Answered by AI
Are there any available slots for volunteers in this experiment?
"This clinical trial is no longer enrolling patients, as evidenced by the most recent update on clinicaltrials.gov from May 5th, 2022. Despite this study finishing recruitment, there are still 782 other active trials that need participants."
Answered by AI
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