Phase 2 Parkinson's Disease Trial, Recruiting NCT07176286 Sponsor: Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Recruiting

NCT07176286
Recruiting Phase 2

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 18 years of age or older at the time of joining the study
  • People who are willing and able to follow the study procedures and have given written consent to participate
  • People who are either male, or female and fall into one of these categories: have had both ovaries and/or uterus surgically removed, have gone through menopause (no periods for more than one year), are not breastfeeding, or have had a negative pregnancy blood test at screening
  • People who have been medically stable for at least 30 days before joining, and remain stable up to the time of the study scan
  • For the Lewy body disease group: People who have been diagnosed with Parkinson's disease (PD) or Dementia with Lewy Bodies (DLB) for at least 6 months before joining
  • For the non-Lewy body disease group: People who have been diagnosed with a neurological or brain-related condition that a neurologist has determined is unlikely to be Parkinson's disease or Dementia with Lewy Bodies, based on accepted medical and imaging assessments

Who may not be able to join:

  • People who have previously been in this study, or who have taken part in another medical research study involving an investigational product or medical device within the last 30 days
  • People with a known or suspected history of serious allergic reactions, including severe allergic shock (anaphylaxis), to any part of the imaging agent used in this study (18F-mFBG)
  • People with another serious, life-threatening illness where life expectancy is less than one year, or where joining the study could interfere with their medical care
  • People with a documented history of ischemic heart disease (such as a prior heart attack or unstable chest pain) or any diagnosis of heart failure
  • People with certain serious non-heart-related medical conditions that cause significantly elevated levels of specific hormones in the blood, including a tumour called pheochromocytoma
  • People who experience claustrophobia (fear of enclosed spaces) or have a movement condition that would prevent them from lying still on their back for up to 20 minutes
  • People with significantly reduced kidney function, as measured by a blood test showing creatinine levels above a certain threshold
  • People taking medications known to interfere with how the imaging agent works, if those medications cannot be safely stopped for 24 hours before the study procedures (confirm with trial site)
  • People who have taken part in research involving radiation exposure in the past 12 months, where joining this study would bring their total research-related radiation dose above a set safety limit

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 26 July 2026
Phase 2: approximately ~30% 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: Juan B Toledo, MD, The Methodist Hospital Research Institute

Phone: 346-238-2677

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 2
Sponsor
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Registry
ClinicalTrials.gov
Start date
30 April 2026
Est. completion
30 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Cohort 1: Quantify the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of subjects with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)).

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: 26 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