Early Phase 1 Parkinson's Disease Trial, Recruiting NCT06289582 Sponsor: University of Alabama at Birmingham Condition: Parkinson's Disease
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Early Phase 1 Parkinson's Disease Trial, Recruiting

NCT06289582
Recruiting Early 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:

  • People who are already enrolled in the PPMI Clinical protocol as either a prodromal Parkinson's disease participant or a healthy participant
  • People with Parkinson's disease who are already enrolled in the PPMI Clinical protocol and have not yet started medication to treat their symptoms at the time of joining, or within the first 2 years of taking part
  • People who are able to give their informed consent to participate
  • People whose genetic screening results show they are a "high binder" at a specific gene variant known as TSPO rs6971
  • Men, or women who meet additional criteria around pregnancy and contraception (see below)
  • Women who are not able to become pregnant — meaning they have had no periods for at least 12 months before the scan, or have had a surgical procedure such as tubal ligation, removal of both ovaries, or a hysterectomy
  • Women who are able to become pregnant and are using a highly effective form of birth control for at least 14 days before and 24 hours after the scan — for example, oral contraceptives used for at least 3 months, an IUD in place for at least 2 months, or barrier methods such as a diaphragm or condom combined with spermicide (note: periodic abstinence methods are not considered acceptable under the trial criteria)
  • Women who are able to become pregnant must not be pregnant, breastfeeding, or lactating, and must have a negative pregnancy test on the day of the scan before the injection

Who may not be able to join:

  • People who have received a total radiation exposure of 50 millisieverts (mSv) or more to the whole body in the past year (this is the annual limit set by US federal regulations)
  • People who have another medical or psychiatric condition, or abnormal lab results, that the trial site investigator believes would make participation unsuitable

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 22 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Jonathan McConathy, MD, PhD, University of Alabama at Birmingham

Phone: 205-934-6499

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
Early Phase 1
Registry
ClinicalTrials.gov
Start date
14 August 2024
Est. completion
1 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD.

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: 22 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