18F-mFBG Imaging for Lewy Body Dementia

18F-mFBG Cardiac Uptake With Lewy Body Dementia

Recruiting Phase 2 Interventional Study
Parkinson Disease (PD) Lewy Body Dementia (LBD)
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 out Ischemic 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?

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About This Trial
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…
Trial Locations
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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…
Contacts

Research Coordinator

346-238-2677

Jrrodriguezgaytan@houstonmethodist.org

CONTACT

Clinical Trials Manager

346-238-1565

Acalmaguerjuarez@houstonmethodist.org

CONTACT