Phase 1 Parkinson's Disease Trial, Recruiting NCT04396873 Sponsor: National Institute of Mental Health (NIMH) Condition: Parkinson's Disease
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Phase 1 Parkinson's Disease Trial, Recruiting

NCT04396873
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people with a neurological condition:

  • Adults aged 18 or older
  • People who are able to understand the study and agree to sign a consent form (or have a legally authorised representative do so on their behalf)
  • People who have been diagnosed by a neurologist or psychiatrist with mild cognitive impairment (MCI), ALS (motor neurone disease), Parkinson's disease, or an adult-onset brain-degenerating condition such as Alzheimer's disease, frontotemporal dementia, corticobasal syndrome, or Huntington's disease
  • People who are in generally good health based on their medical history and a physical check-up
  • People whose wrist pulse has been checked to confirm adequate blood flow and no metal objects present in either wrist
  • People who agree to follow the lifestyle guidelines set out by the study

For healthy volunteers:

  • Adults aged 18 or older
  • Women who could become pregnant must be using a medically accepted form of contraception
  • People who are able to provide informed consent
  • People who are in generally good health with no signs of cognitive impairment, based on medical history and physical check-up
  • People already enrolled in one of two specific NIMH research programs (confirm with trial site)
  • People whose wrist pulse has been checked to confirm adequate blood flow and no metal objects present in either wrist
  • People who agree to follow the lifestyle guidelines set out by the study

Who may not be able to join:

  • People with significantly abnormal results on an electrocardiogram (heart tracing) or blood tests, including a creatinine level above 1.3 mg/dL or other values more than twice the normal upper limit
  • People who have taken anti-inflammatory medications (such as ibuprofen or naproxen) in the two weeks before the PET scan, or who have taken aspirin, steroid medications (other than skin creams), or immune-suppressing drugs (such as methotrexate) in the month before the scan
  • People who are allergic to ketoprofen or have a history of stomach or intestinal bleeding
  • People who have other major neurological or medical conditions that could affect thinking or memory, such as structural brain disease, metabolic disorders, cancer-related brain syndromes, or infections
  • People with an unstable medical condition that the study doctors consider unsafe, such as an active infection or untreated cancer
  • People who are unable to travel to the NIH (National Institutes of Health)
  • People who have recently taken part in other research involving radiation (such as other PET scans) where the combined radiation exposure would exceed allowable limits
  • People who are unable to lie flat and stay still on the scanner bed for at least two hours — this includes people with claustrophobia, people who exceed the scanner's weight limit, or people with behavioural symptoms that cannot be controlled
  • People with a diagnosed substance use disorder or alcohol use disorder (note: alcohol or cannabis use on its own is not an exclusion unless it affects daily functioning)
  • People who are currently being treated with, or have previously been treated with, the drug Aduhelm (aducanumab)
  • People who are unable to have an MRI scan due to implanted metal devices or objects, including pacemakers, brain stimulators, aneurysm clips, metal prostheses, cochlear implants, permanent eyeliner, implanted pumps, or metal fragments in the eye
  • People who are pregnant
  • People with HIV infection
  • People who are NIMH staff, NIH employees, or a relative, subordinate, or close colleague of the study investigators

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Robert B Innis, M.D., National Institute of Mental Health (NIMH)

Phone: (301) 827-6599

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
17 August 2021
Est. completion
11 April 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Measure the concentration of radioligands

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov