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NCT04396873 · ClinicalTrials.gov registry record · Phase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
A Phase 1 study of Mild Cognitive Impairment and Dementia, sponsored by National Institute of Mental Health (NIMH).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 184
- Enrollment target
- 1
- Study location
NCT04396873 is a Phase 1 study of Mild Cognitive Impairment and Dementia that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 184 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04396873, a Phase 1 study of Mild Cognitive Impairment and Dementia, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 184 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation. Objective: To learn whether COX-1 and/or COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers. Eligibility: Adults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181. Design: Participants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured. Participants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs. Participants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan. Participants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.
Conditions Studied
Interventions
- DRUG 11C-MC1
- DRUG 11C-PS13
- DRUG 18f-florbetaben
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2021-08-17 |
| Est. Completion | 2030-10-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04396873
The ClinicalTrials.gov registry entry for NCT04396873 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (86% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 3 interventions - of which 11C-MC1 is the first listed.
NCT04396873 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04396873 about?
NCT04396873 is a clinical study titled "PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease". Background: About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation. Objective: To learn ...
What is the current status of trial NCT04396873?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 184 participants. The study started on 2021-08-17. Estimated completion is 2030-10-03.
What conditions does trial NCT04396873 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Dementia, Parkinson's Disease, Alzheimers Disease, ALS.
What interventions are being tested in trial NCT04396873?
The interventions under investigation include: 11C-MC1 (DRUG), 11C-PS13 (DRUG), 18f-florbetaben (DRUG).
Who is sponsoring clinical trial NCT04396873?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04396873 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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