RecruitingPhase 1interventionalRules rewrite

Phase 1: testing 11C-MC1 for Parkinson's Disease

Background: About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder.

Official registry: https://clinicaltrials.gov/study/NCT04396873 · National Institute of Mental Health (NIMH) · enrollment listed as 184

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are 11C-MC1, 11C-PS13, or 18f-florbetaben. The registry lists allocation as na. Background: About 5 million adults in the U.S.

They plan to enroll about 184 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase 1 Study: PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease

Interventions: 11C-MC1, 11C-PS13, 18f-florbetaben

Primary outcome (registry wording): Measure the concentration of radioligands

Who it is for (from inclusion criteria)

Ages 18 Years to 99 Years
Patients: In order to be eligible to participate in this study, patients must meet all of the following criteria:
Have been diagnosed by a neurologist or psychiatrist with MCI, ALS, PD, or an adult onset neurodegenerative dementia, such as AD (including amyloid negative subjects), FTD, corticobasal syndrome, or Huntington s disease
Be in good general health as evidenced by medical history and physical examination
Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists
Agree to adhere to the lifestyle considerations
Healthy volunteers: In order to be eligible to participate in this study, healthy volunteer subjects must meet all of the following criteria:
Female participants of childbearing potential must be using a medically acceptable means of contraception

Who the registry excludes

Both patients and healthy volunteers who meet any of the following criteria will be excluded from participation in this study:
Subjects should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAID) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month
Contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding
Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities
Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy)
Are unable to travel to the NIH
Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits

Public study contact (from the registry)

Tara N Turon, C.R.N.P.

(301) 827-6599

tara.turon@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

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FAQ about this NCT record

Is NCT04396873 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04396873?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04396873?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary