No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
20 (estimated)
Sponsor
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · Industry
Who this trial is looking for
This trial is looking for adults with Lewy body dementia or other neurological diseases to study a special imaging technique. Participants will have imaging of the heart to help understand these conditions better.
Are You a Good Fit for This Trial?
Rules you outIschemic heart diseaseHeart failureRenal insufficiency
You may be able to join if
I am at least 18 years old.
I can follow study procedures and have signed the consent form.
I am either surgically sterile, postmenopausal, non-lactating, or my pregnancy test is negative.
I have been clinically stable for at least 30 days before joining.
I have a diagnosis of Parkinson's disease or dementia with Lewy bodies.
I have a diagnosis of a neurological disease that is not Parkinson's disease or dementia with Lewy bodies.
You may not be able to join if
I have been part of this study before.
I have a history of serious allergic reactions to the study drug.
I have a serious, life-threatening illness with less than 1 year to live.
I have heart disease or heart failure.
I have a serious non-cardiac condition causing high catecholamines.
I cannot lie still for up to 20 minutes.
I have kidney problems with high serum creatinine levels.
I take medications that interfere with the imaging agent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 compar…
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 Locations
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City
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Status
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), postmenopau…
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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