Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Mild Cognitive Impairment and Dementia, sponsored by National Institute of Mental Health (NIMH).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Density of COX-1 and COX-2 in brain
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 |
What NCT04396873 shows while recruiting
NCT04396873 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Mild Cognitive Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04396873's enrollment target sits among peer trials
184 55th of 205 higher than 151 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
rTMS to Improve Cognition in Parkinson's
RECRUITING · Phase 1
-
Sense4Safety Intervention
RECRUITING · Phase 1
-
CogT pSOPT Intervention Study
RECRUITING · Phase 1
-
Safety and Target Engagement of Centella Asiatica in Cognitive Impairment
RECRUITING · Phase 1
-
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
RECRUITING · Phase 1
-
Innate Immunity Stimulation Via TLR9 in Early AD
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03903510 · 184 participants · NA
Virtual Reality During Pediatric Cast Removal
- NCT04020510 · 184 participants · Phase 4
Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
- NCT04135846 · 184 participants · Phase 2
Alpha-1 Blockade for Alcohol Use Disorder (AUD)
- NCT04700332 · 184 participants · Phase 2
PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI