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18F-mFBG Cardiac Uptake With Lewy Body Dementia

Study acronym: IRP101-231
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from Sep 30, 2026 to Oct 30, 2026 Completion pushed from Oct 30, 2026 to Dec 30, 2026 · Start date changed from estimate of Apr 15, 2026 to Apr 30, 2026v5 Show 2 more changesShow less
    • Completion pushed from Oct 30, 2026 to Dec 30, 2026
    • Start date changed from estimate of Apr 15, 2026 to Apr 30, 2026
  2. Trial status: Not Yet Recruiting to Recruiting Start date: Nov 30, 2025 to Apr 15, 2026 · Study sites: 0 to 1 · Primary completion date: May 30, 2026 to Sep 30, 2026 · 1 morev4 Show 4 more changesShow less
    • Start date: Nov 30, 2025 to Apr 15, 2026
    • Study sites: 0 to 1
    • Primary completion date: May 30, 2026 to Sep 30, 2026
    • Completion date: Jul 30, 2026 to Oct 30, 2026
  3. Start date: Oct 30, 2025 to Nov 30, 2025 Primary completion date: Apr 30, 2026 to May 30, 2026 · Completion date: Jun 30, 2026 to Jul 30, 2026v3 Show 2 more changesShow less
    • Primary completion date: Apr 30, 2026 to May 30, 2026
    • Completion date: Jun 30, 2026 to Jul 30, 2026
  4. Study title expanded, about 1 wordv2 See this version in full on ClinicalTrials.gov ↗
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.
Trial Details
NCT Number NCT07176286
Lead Sponsor Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Conditions Parkinson Disease (PD), Lewy Body Dementia (LBD)
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov