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PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 418 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Eligibility criteria expanded, about 28 words
    • Study description revised
  2. Minor 11 versions Re-verified since Nov 23, 2024, no change to tracked fieldsv407-v417
  3. Minor Study description expanded, about 9 wordsv406
  4. Minor Enrollment target: 168 to 184
    • Eligibility criteria revised
    v405
  5. Minor 8 versions Re-verified since Feb 28, 2024, no change to tracked fieldsv397-v404
Show 28 earlier versionsHide 28 earlier versions
  1. Notable Primary completion date: Apr 11, 2026 to Apr 11, 2029
    • Study completion date: Oct 3, 2027 to Oct 3, 2030
    v396
  2. Minor 2 versions Re-verified since Jan 4, 2024, no change to tracked fieldsv394-v395
  3. Minor Enrollment target: 158 to 168v393
  4. Minor 3 versions Re-verified since Aug 16, 2023, no change to tracked fieldsv390-v392
  5. Minor Eligibility criteria expanded, about 1 wordv389
  6. Minor Enrollment target: 136 to 158v388
  7. Minor Re-verified, no change to tracked fieldsv387
  8. Notable Primary completion date: Apr 11, 2023 to Apr 11, 2026
    • Study completion date: Oct 3, 2024 to Oct 3, 2027
    v386
  9. Minor 11 versions Re-verified since Jun 29, 2022, no change to tracked fieldsv375-v385
  10. Minor Enrollment target: 120 to 136v374
  11. Minor 5 versions Re-verified since Jun 17, 2022, no change to tracked fieldsv369-v373
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,978 trials monitored
See 106 trials at risk
and 1 more 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 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.
Trial Details
NCT Number NCT04396873
Lead Sponsor National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Parkinson's Disease, Dementia, Alzheimer's Disease, ALS, Mild Cognitive Impairment
Related terms Alzheimer Disease, Cognitive Dysfunction, Dementia, Inflammation, Parkinson Disease
Enrollment 184 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov