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Dementia / 11C-PS13 / 18F-florbetaben · Phase 1 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 PET imaging study registered to investigate whether cyclooxygenase-1 and/or cyclooxygenase-2 are elevated in the brains of patients with Alzheimer's disease, Parkinson's disease, ALS, and other neurodegenerative conditions compared to healthy volunteers. The study is currently recruiting and has not reported results; this registry entry describes the planned methodology and enrolled population only.
Phase 1, Interventional, Single Group, Open label, Diagnostic purpose. Parkinson's Disease, Dementia, Alzheimer's Disease, ALS, Mild Cognitive Impairment; age from 18 Years; to 99 Years; accepts healthy volunteers. Intervention: Only one arm. Compared with: Healthy adult volunteers without neurodegenerative disease. n = 184. 1 site: United States.
This is a Phase 1 PET imaging study registered to investigate whether cyclooxygenase-1 and/or cyclooxygenase-2 are elevated in the brains of patients with Alzheimer's disease, Parkinson's disease, ALS, and other neurodegenerative conditions compared to healthy volunteers. The study is currently recruiting and has not reported results; this registry entry describes the planned methodology and enrolled population only.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a Phase 1 interventional registry record with no results posted; it describes a planned imaging study to measure cyclooxygenase elevation in neurodegenerative disease versus controls, but enrollment is ongoing and no outcomes have been reported.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04396873). This is a study registration, not published results. Lead sponsor: National Institute of Mental Health (NIMH). Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 184 participants (ESTIMATED). Conditions: Parkinson's Disease, Dementia, Alzheimer's Disease, ALS, Mild Cognitive Impairment. Interventions: DRUG: 11C-MC1; DRUG: 11C-PS13; DRUG: 18f-florbetaben. Primary outcome measures: Measure the concentration of radioligands , 1-2 days. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.