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RecruitingPhase 1

PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits
  • Procedures mentioned: Physical exams, MRI scans, PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: Participants will be screened with medical history, physical exam with vital signs, and lab tests."
  • "Participants will have a magnetic resonance imaging (MRI) scan."
  • "The MRI scanner is a metal tube surrounded by a strong magnetic field."
  • "Participants will have 2 PET scans."
  • "Participants will have 2-5 study visits."
  • "Secondary Objective: 1\) To determine retest variability and reliability for each radioligand. 2) To evaluate the specific binding of \[11C\]PS13 to COX-1 in healthy subjects through blocking study using Ketoprofen, a COX-1 inhibitor Endpoints: Primary Endpoint: Measurement of COX-1 and COX-2 density in brain after PET scans with \[11C\]PS13 and \[11C\]MC1, respectively."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses PET brain scans to see whether two proteins linked to inflammation, COX-1 and COX-2, are higher in people with certain brain diseases. It is for adults with these diseases and healthy adult volunteers.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and in good general health.
  • Patients must have a diagnosis from a brain or mental health doctor: mild cognitive impairment (memory or thinking problems), ALS, Parkinson’s disease, or an adult-onset disease such as Alzheimer’s, frontotemporal dementia, corticobasal syndrome, or Huntington’s disease.
  • Patients or their legally authorized representative must understand the study and agree in writing. Healthy volunteers must give their own consent.
  • Healthy volunteers must have no memory or thinking problems and be enrolled in NIH study 01-M-0254 or 17-M-0181.
  • Healthy female volunteers who could become pregnant must use medically accepted birth control.
  • Have wrist blood flow checked, with enough backup blood flow and no metal or other foreign objects in either wrist.
  • Agree to follow the study’s lifestyle rules.

Who can't join

  • Have important abnormal heart tracing or blood test results, including a creatinine level above 1.3 mg/dL, which may signal kidney problems.
  • Used NSAIDs (anti-inflammatory pain medicines) within two weeks before the PET scan; or aspirin, steroids other than skin products, or medicines that weaken the immune system within the past month.
  • Cannot safely take ketoprofen, a pain medicine, because of an allergy or past stomach or bowel bleeding; or have ever received Aduhelm.
  • Have another major illness that can affect thinking, an unstable illness that makes the study unsafe, or HIV infection.
  • Cannot travel to NIH, cannot lie flat and still for at least two hours, exceed the scanner’s weight limit, or cannot safely have an MRI.
  • Are pregnant, or have had research-related radiation that would exceed allowed limits when added to this study.
  • Have a drug or alcohol use disorder. Alcohol or cannabis use alone does not rule you out unless it affects daily life.
  • Are NIMH staff, or an NIH employee who works under, is related to, or works alongside the study researchers.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION CRITERIA: Patients: In order to be eligible to participate in this study, patients must meet all of the following criteria: 1. Aged 18 or older. 2. Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document. 3. 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. 4. Be in good general health as evidenced by medical history and physical examination. 5. 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. 6. 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: 1. Aged 18 or older. 2. Female participants of childbearing potential must be using a medically acceptable means of contraception 3. Able provide informed consent. 4. Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment. 5. Be enrolled in 01-M-0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17-M-0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies 6. 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. 7. Agree to adhere to the lifestyle considerations. EXCLUSION CRITERIA: Both patients and healthy volunteers who meet any of the following criteria will be excluded from participation in this study: 1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \>1.3 mg/dL 2. 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. 3. Contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding. 4. 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. 5. Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy). 6. Are unable to travel to the NIH. 7. 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. 8. Have an inability to lie flat and/or lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the patient and/or caregiver during the screening visit. 9. Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life. 10. Participants should not be under treatment with Aduhelm, nor should they have been treated in the past. 11. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye). 12. Pregnancy 13. HIV infection 14. Be NIMH staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.

Study sites (1)

MD