18F-mFBG Cardiac Uptake With Lewy Body Dementia
An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F-mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With and Without Lewy Body Diseases
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This Phase 2 study tests 18F-mFBG, a radioactive imaging drug, to measure how brain and nerve diseases affect nerves in the heart. It is for adults with Parkinson’s disease, dementia with Lewy bodies, or other brain or nerve diseases. Researchers will compare heart scan results between these groups and with past results from healthy people.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are at least 18 years old.
- You can and will follow study steps and sign a consent form.
- You are male, or you are female and meet the listed rules about surgery to remove the ovaries or womb, menopause, not breastfeeding, or a negative blood pregnancy test.
- Your health has been stable for at least 30 days before joining and stays stable until the scan.
- For the Lewy body group: You were diagnosed with Parkinson’s disease or dementia with Lewy bodies at least 6 months before joining.
- For the other group: You have a brain or nerve disease, and a nerve specialist thinks Parkinson’s disease and dementia with Lewy bodies are unlikely.
Who can't join
- You have already joined this study, or you took part in another study of an experimental drug or medical device within the past 30 days.
- You have had, or may have had, a serious allergic reaction to any part of the imaging drug.
- You have a serious active illness with a life expectancy under 1 year, study participation could harm your care, or the study doctor finds another reason you should not join.
- You have heart disease caused by poor blood flow, such as a past heart attack or unstable chest pain, or heart failure from any cause.
- You have a serious illness outside the heart that greatly raises certain stress hormones, such as a tumor called pheochromocytoma.
- Fear of closed spaces or a movement problem keeps you from lying still on your back for up to 20 minutes.
- You have poor kidney function, with blood creatinine above 3.0 mg/dL, or take medicines that affect the scan and cannot safely stop them 24 hours before study steps.
- Radiation from research in the past 12 months, plus this study, could put your total research radiation dose above 50 millisieverts.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
TX
- Houston Methodist Neurological Institute · Houston, TX 77030Juan B Toledo, MD · Study contact · 713-441-1150 · jtoledo@houstonmethodist.orgMore trials in Houston