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TSPO Radioligand PET Imaging for Neurodegenerative Disease

Phase 1
Waitlist Available
Led By Robert B Innis, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with an increased risk of neurodegenerative diseases age 18 or older, able to give written informed consent, and have known family history or other risk of an adult-onset genetic neurodegenerative disease, and/or mutation in a gene known to cause an adult-onset neurodegenerative disease
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a drug to see if it can show brain inflammation in people with certain progressive neurological disorders compared to healthy adults, as well as finding genes associated with these disorders.

Who is the study for?
Adults aged 18+ with neurodegenerative diseases like Alzheimer's, or at risk due to family history/genetic factors, and healthy adults for comparison. Participants must be able to consent (or have a guardian who can), lie flat for scans, and not be pregnant/breastfeeding or have conditions that could affect the study.Check my eligibility
What is being tested?
The trial tests if the drug [11C]ER176 can detect brain inflammation in people with neurological disorders versus healthy adults using PET scans. It also aims to identify genes linked to these disorders through blood tests and DNA analysis over multiple sessions spanning up to 5 years.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still during scans, reactions at injection sites of radioactive drugs, temporary side effects from MRI contrast agents if used, and anxiety related to claustrophobia inside scanners.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are 18 or older, able to give permission in writing, and have a family history or other risk of developing an adult-onset genetic brain disease, or have a gene mutation linked to an adult-onset brain disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Distribution of inflammation in brain determined with PET imaging
Secondary outcome measures
Inflammation

Trial Design

1Treatment groups
Experimental Treatment
Group I: PET scanExperimental Treatment2 Interventions
Healthy and Patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
11C-ER176
2018
Completed Phase 2
~10

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,774 Previous Clinical Trials
2,674,290 Total Patients Enrolled
25 Trials studying Dementia
7,548 Patients Enrolled for Dementia
Robert B Innis, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
27 Previous Clinical Trials
1,291 Total Patients Enrolled
2 Trials studying Dementia
276 Patients Enrolled for Dementia

Media Library

11C-ER176 Clinical Trial Eligibility Overview. Trial Name: NCT03958630 — Phase 1
Dementia Research Study Groups: PET scan
Dementia Clinical Trial 2023: 11C-ER176 Highlights & Side Effects. Trial Name: NCT03958630 — Phase 1
11C-ER176 2023 Treatment Timeline for Medical Study. Trial Name: NCT03958630 — Phase 1

Frequently Asked Questions

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

Is this experiment actively seeking volunteers?

"According to the data available on clinicaltrials.gov, this experimental intervention is currently open for participants in need of treatment. The trial was first made public on July 3rd 2019 and had its most recent update posted at the end of September 2022."

Answered by AI

How many participants can enroll in this experiment?

"Correct. According to cliniciansltrials.gov, this inquiry has been posted since July 3rd 2019 and was recently updated on September 30th 2022. The research is recruiting 200 individuals across one site."

Answered by AI

Are there any Food and Drug Administration authorizations associated with 11C-ER176?

"Taking into account its Phase 1 classification, our team at Power assigned 11C-ER176 a score of 1 due to the scant evidence that supports both safety and efficacy."

Answered by AI
~2 spots leftby Mar 2025