Actively Recruiting

Phase 1
Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT04396873

PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease

Led by National Institute of Mental Health (NIMH) · Updated on 2026-04-24

184

Participants Needed

1

Research Sites

476 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Able to understand the study and willing to sign informed consent (or have a legally authorized representative do so)
  • Diagnosed by a neurologist or psychiatrist with mild cognitive impairment, ALS, Parkinson's disease, or adult-onset neurodegenerative dementia such as Alzheimer's disease, frontotemporal dementia, corticobasal syndrome, or Huntington's disease
  • In good general health based on medical history and physical exam
  • Radial artery pulse checked with adequate ulnar collateral flow and no metal or foreign objects in wrists
  • Agree to follow lifestyle considerations
  • For healthy volunteers: female participants of childbearing potential must use medically acceptable contraception
  • Healthy volunteers must have no cognitive impairment and be enrolled in specified NIH protocols
Not Eligible

You will not qualify if you...

  • Significant abnormalities on EKG or lab tests including CBC and metabolic panel
  • Creatinine level over 1.3 mg/dL
  • Use of NSAIDs within two weeks prior to PET scan
  • Use of aspirin, corticosteroids (except skin products), or immunosuppressants within one month prior
  • Allergic or hypersensitive to ketoprofen or history of gastrointestinal bleeding
  • Other major neurological or medical diseases causing cognitive dysfunction
  • Unstable medical conditions such as active infection or untreated cancer
  • Unable to travel to NIH
  • Recent radiation exposure exceeding allowed limits
  • Unable to lie still or lie flat for at least two hours due to claustrophobia, weight, or behavior
  • Substance use disorder or alcohol use disorder that impairs daily function
  • Current or prior treatment with Aduhelm
  • Unable to have MRI due to implants, metal fragments, or other contraindications
  • Pregnancy
  • HIV infection
  • NIH staff who are subordinates, relatives, or co-workers of investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

T

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

CONTACT

R

Robert B Innis, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease | DecenTrialz