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Phase 2Recruiting

18F-mFBG Cardiac Uptake With Lewy Body Dementia

Sponsored by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

About this study

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.

Over the past 40 years, significant efforts have been made to develop imaging techniques to monitor the heart's autonomic nervous system, particularly the sympathetic system and its key neurohormone, norepinephrine (NE). In heart disease, NE function is often disrupted, leading to reduced NE uptake and transporter expression, which can contribute to heart failure, arrhythmias, and sudden cardiac death. Similar NE system dysfunction is also seen in neurological conditions like pure autonomic failure (PAF), Parkinson's disease (PD), and Dementia with Lewy Bodies (DLB), which are associated with Lewy body deposits in the nervous system. Most research on myocardial sympathetic neuronal imaging has focused on NE-analogues labeled with gamma- or positron-emitting radioisotopes. The most commonly…

Where this study is enrolling

Who can participate

Inclusion criteria

  • ✓1\. ≥18 years of age at study entry. 2. Able and willing to comply with study procedures and signed and dated informed consent is obtained.
  • ✓3\. A male or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a serum pregnancy test performed at screening is negative.
  • ✓4\. All subjects: Judged clinically stable for at least 30 days before enrolment into the study and remains stable to the time of the study imaging procedure.
  • ✓For Lewy body disease subjects (Study Cohort I):
  • ✓5\. The subject has a diagnosis of either PD or DLB based on accepted clinical criteria at least 6 months before enrollment into the study.
  • ✓For non-Lewy body disease subjects (Study Cohort II):
  • ✓6\. The subject has a diagnosis of neurological or neurodegenerative disease for which neither PD nor DLB is judged likely by a neurologist based on accepted clinical and imaging criteria.

Exclusion criteria

  • ✕1\. Previously entered into this study or has participated in any other investigational product or medical device study within 30 days of enrollment.
  • ✕2\. History or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.
  • ✕3\. Presents with any other clinically active, serious, life-threatening disease with a life expectancy of less than 1 year or where participation in the study might compromise the management of the subject or other reason that in the judgment of the investigator(s) makes the subject unsuitable for participation in the study.
  • ✕4\. Documented ischemic heart disease (prior myocardial infarction, unstable angina, etc) or a diagnosis of heart failure of ischemic or non-ischemic etiology.
  • ✕5\. Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including pheochromocytoma.
  • ✕6\. The subject is claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to 20 minutes.
  • ✕7\. Renal insufficiency (serum creatinine \>3.0 mg/dL). 8. Uses medications that are known to interfere with uptake of NET-dependent agents and these medications cannot be safely withheld 24 hours before study procedures.
  • ✕9\. Participated in a research study using ionizing radiation in the previous 12 months such that participation in the study might result in a total effective dose from research procedures exceeding 50 milliSieverts during that time interval.

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Trial data sourced from ClinicalTrials.gov.