18F-mFBG Cardiac Uptake With Lewy Body Dementia

NCT07176286 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRP101-231
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease (PD); Lewy Body Dementia (LBD)

Keywords

IRP101-231; 18F-mFBG

Outcome Measures

Primary Outcomes (1)

• Cohort 1: Quantify the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of subjects with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)).

  All image data will be analyzed to develop and validate quantitative measures of global and regional myocardial uptake of 18F-mFBG at two times between injection and 60 minutes post-administration. The data from subjects without Lewy body disease will be used in comparisons with equivalent results for Lewy body disease subjects. Results for subjects imaged in this study will also be compared with historical data from imaging of healthy control subjects without heart disease.

  6 months

Secondary Outcomes (3)

• Cohorts 1 and 2: Quantify 18F-mFBG whole-body activity distribution in Lewy body disease subjects (voxel, regional, and global basis) at 30-minutes post-administration

  6 months

• Cohort 1 and 2: 18F-mFBG PET quantitative assessment at 60 minutes

  6 months

• Cohorts 1 and 2: Global myocardial 18F-mFBG activity in Lewy body disease subjects compared to non-Lewy body disease subjects.

  6 months

Study Arms (2)

Cohort 1: Known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)

ACTIVE COMPARATOR

All subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes.

Drug: 18F-MFBG

Cohort 2: neurologic disease due to non-Lewy body pathology.

ACTIVE COMPARATOR

All subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes.

Drug: 18F-MFBG

Interventions

18F-MFBG DRUG

Intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG followed by whole body PET imaging.

Cohort 1: Known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD); Cohort 2: neurologic disease due to non-Lewy body pathology.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. ≥18 years of age at study entry. 2. Able and willing to comply with study procedures and signed and dated informed consent is obtained.
• \. 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.
• \. 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):
• \. 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):
• \. 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.

You may not qualify if:

• \. Previously entered into this study or has participated in any other investigational product or medical device study within 30 days of enrollment.
• \. History or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.
• \. 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.
• \. Documented ischemic heart disease (prior myocardial infarction, unstable angina, etc) or a diagnosis of heart failure of ischemic or non-ischemic etiology.
• \. Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including pheochromocytoma.
• \. 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.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC): lead

Study Sites (1)

Houston Methodist Neurological Institute

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Lewy Body Disease

Interventions

3-fluorobenzylguanidine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Neurocognitive Disorders; Mental Disorders

Study Officials

• Juan B Toledo, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

346-238-2677; Jrrodriguezgaytan@houstonmethodist.org

Clinical Trials Manager

CONTACT

346-238-1565; Acalmaguerjuarez@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an exploratory study of two study cohorts. Cohort 1 will consist of a minimum of five and maximum of ten participants with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)). Cohort 2 will consist of participants with neurologic disease due to non-Lewy body pathology.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 16, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)