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NCT03958630 · ClinicalTrials.gov registry record · Phase 1

PET Imaging of Neuroinflammation in Neurodegenerative Diseases Via a Novel Translocator Protein (TSPO) Radioligand

A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).

Terminated
Registry status
Phase 1
Development phase
13
Enrollment target

NCT03958630 is a Phase 1 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 13 participants.

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The verdict

NCT03958630, a Phase 1 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).

TERMINATED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

Background: Aging-related progressive neurological disorders include frontotemporal dementia, Lou Gehrig s disease, and Alzheimer s disease. Little is known about what causes these disorders. Brain inflammation may be involved. Researchers want to see if scans using radioactive drugs can show brain inflammation. Objective: To see if the drug \[11C\]ER176 can show inflammation in the brain in people with certain progressive neurological disorders compared to healthy adults. Also to find genes that might be associated with or cause these disorders. Eligibility: People ages 18 and older with an aging-related neurological disorder, and healthy adults Design: Participants will be screened with a medical history, physical exam, neurological exam, psychiatric history, and blood tests. Participants will have 2-5 visits for the first session. They will have 2 PET scans and 1 MRI scan. They may have 3 more sessions: 6 months to about 18 months later, 1 year after that, and about 30 months to 5 years after the first visit. There may be up to 20 total visits. For the scans, participants will lie on a bed that slides into the scanners. For the PET scans, a strap will fix their head in place. A radioactive drug will be injected through a catheter. A needle will guide a thin plastic tube into an arm vein. Additional catheters may be put in place to draw blood. Each PET will take 2 hours. The MRI will take 30 60 minutes. At each session, participants will have a brief interview, medical history, physical exam, blood and urine tests, heart tests, and memory and thinking tests. They may donate blood for DNA tests.

Interventions

  • DRUG 11C-ER176
  • DIAGNOSTIC_TEST Positron Emission Tomography (PET) Scan
  • DRUG 11C-PIB

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2019-07-03
Est. Completion 2023-12-04
Phase Phase 1

What the Registry Record Tells You About NCT03958630

The ClinicalTrials.gov registry entry for NCT03958630 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which 11C-ER176 is the first listed.

NCT03958630 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03958630 about?

NCT03958630 is a clinical study titled "PET Imaging of Neuroinflammation in Neurodegenerative Diseases Via a Novel Translocator Protein (TSPO) Radioligand". Background: Aging-related progressive neurological disorders include frontotemporal dementia, Lou Gehrig s disease, and Alzheimer s disease. Little is known about what causes these disorders. Brain inflammation may be involved. Researchers want to see if scans using radioactive drugs can show brain...

What is the current status of trial NCT03958630?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2019-07-03. Estimated completion is 2023-12-04.

What interventions are being tested in trial NCT03958630?

The interventions under investigation include: 11C-ER176 (DRUG), Positron Emission Tomography (PET) Scan (DIAGNOSTIC_TEST), 11C-PIB (DRUG).

Who is sponsoring clinical trial NCT03958630?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.