MIBG in Aging and Neurologic Disorders
Primary Purpose
Lewy Body Disease, Dementia, Parkinsonism
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
meta-iodobenzylguanidine (MIBG) (123I)
123I-MIBG scintigraphy
Sponsored by
About this trial
This is an interventional diagnostic trial for Lewy Body Disease focused on measuring REM Sleep without atonia, Normal Neurologic functioning
Eligibility Criteria
Inclusion Criteria
- Diagnosis of one of the syndromes/diagnoses of interest using established criteria
- STMS score above 10
- No active medical disorder that could preclude participation
- Stable medication regimen over previous four weeks
- Absence of certain medications that could significantly impact the myocardial 123I-MIBG scintigraphy findings
- For those with dementia, caregiver that is with the patient at least 4 hours/day for at least 5 days per week
- For those with dementia, or severe parkinsonism, patient and caregiver willing and able to participate in all study-related procedures
- Patient is capable of giving informed consent, or if appropriate, has caregiver capable of giving consent on the subject's behalf.
Exclusion Criteria
- Does not fulfill criteria for any of the desired diagnoses
- Women with intact uterus and not post-menopausal unless pregnancy test performed at screening is negative
- Women who are pregnant or are breast-feeding an infant
- STMS score <10
Active medical disorder that could preclude participation in this protocol
- Hypersensitivity to the radioligand or iodine
- Myocardial infarction or cerebral infarct over preceding year, stable or unstable angina, known symptomatic coronary artery disease
- Renal disease viewed by the physician to be too severe to warrant myocardial 123I-MIBG scintigraphy imaging
- History of significant alcohol or drug abuse
- Any other medical disorder considered by the study physicians as inappropriate for enrollment in this protocol
- Patient or caregiver unwilling or unable to participate in all study-related procedures
- Caregiver is not with a patient with dementia or severe parkinsonism at least 4 hours/day for at least 5 days/week
- Patient or caregiver unwilling or unable to provide informed consent
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Myocardial 123I-MIBG scintigraphy imaging
Arm Description
Subjects with with normal neurologic functioning, REM sleep without atonia, RBD, parkinsonism, cognitive impairment, or some combination of these will undergo myocardial 123I-MIBG scintigraphy imaging
Outcomes
Primary Outcome Measures
Correlate myocardial 123I-MIBG scintigraphy findings
Number of myocardial 123I-MIBG scintigraphy findings to correlate with clinical pathologic diagnosis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05514106
Brief Title
MIBG in Aging and Neurologic Disorders
Official Title
Myocardial 123I-MIBG Scintigraphy in Aging and Neurodegenerative Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to investigate the use of a special radioactive drug called 123I-MIBG and myocardial MIBG scintigraphy. This scan may be able to help determine who may have a certain kind of neurologic disorder called Lewy Body Disease.
The overall purpose of this study is to correlate myocardial MIBG scintigraphy findings with clinical diagnosis. Myocardial MIBG scintigraphy imaging will be combined with other clinical, neuropsychological and neuroimaging findings to improve the prediction for underlying Lewy Body Disease.
Detailed Description
Lewy body disease (LBD) is one of the most common neurodegenerative diseases and second only to Alzheimer's disease in terms of prevalence, disability, and societal/financial burden. The clinical variability of LBD is striking, as it can manifest as Parkinson's disease (PD), PD with dementia (PDD), dementia with Lewy bodies (DLB), mild cognitive impairment (MCI), REM sleep behavior disorder (RBD), among other disorders. Considerable evidence now suggests that accumulation of the pathological protein and neuronal loss evolve over decades with RBD and/or MCI beginning years before developing overt DLB or PD.
This project investigates the utility of myocardial 123I-MIBG scintigraphy using a radioactive agent AdreView™ in participants with normal neurologic functioning, REM sleep without atonia, RBD, parkinsonism, cognitive impairment, or some combination of these. This scan may be able to help determine who may have underlying LBD.
Myocardial 123I-MIBG scintigraphy is considered as one of the most important imaging tests in the international diagnostic criteria of DLB, and it is widely used in European countries and Japan. Despite its globally recognized scientific importance, the use of AdreView™ and myocardial 123I-MIBG scintigraphy in DLB and associated disorders is not approved in the US. Currently, the FDA-approved indication of AdreView™ is limited to assessing specific cardiac function and detecting pheochromocytoma or neuroblastoma.
The overall purpose of this study is to correlate myocardial MIBG scintigraphy findings with clinical diagnosis. Myocardial MIBG scintigraphy imaging will be combined with other clinical, neuropsychological and neuroimaging findings to improve the detection of LBD. This study will help investigators learn the utility of myocardial 123I-MIBG scintigraphy in identifying LBD in the early course of the disease, and to prepare for clinical trials targeting LBD pathophysiology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lewy Body Disease, Dementia, Parkinsonism, Mild Cognitive Impairment, REM Sleep Behavior Disorder
Keywords
REM Sleep without atonia, Normal Neurologic functioning
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myocardial 123I-MIBG scintigraphy imaging
Arm Type
Experimental
Arm Description
Subjects with with normal neurologic functioning, REM sleep without atonia, RBD, parkinsonism, cognitive impairment, or some combination of these will undergo myocardial 123I-MIBG scintigraphy imaging
Intervention Type
Drug
Intervention Name(s)
meta-iodobenzylguanidine (MIBG) (123I)
Other Intervention Name(s)
123I-MIBG
Intervention Description
1 administration of 123I-MIBG for a single SPECT scan
Intervention Type
Diagnostic Test
Intervention Name(s)
123I-MIBG scintigraphy
Intervention Description
SPECT scan involving 123I-MIBG as the ligand
Primary Outcome Measure Information:
Title
Correlate myocardial 123I-MIBG scintigraphy findings
Description
Number of myocardial 123I-MIBG scintigraphy findings to correlate with clinical pathologic diagnosis
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Diagnosis of one of the syndromes/diagnoses of interest using established criteria
STMS score above 10
No active medical disorder that could preclude participation
Stable medication regimen over previous four weeks
Absence of certain medications that could significantly impact the myocardial 123I-MIBG scintigraphy findings
For those with dementia, caregiver that is with the patient at least 4 hours/day for at least 5 days per week
For those with dementia, or severe parkinsonism, patient and caregiver willing and able to participate in all study-related procedures
Patient is capable of giving informed consent, or if appropriate, has caregiver capable of giving consent on the subject's behalf.
Exclusion Criteria
Does not fulfill criteria for any of the desired diagnoses
Women with intact uterus and not post-menopausal unless pregnancy test performed at screening is negative
Women who are pregnant or are breast-feeding an infant
STMS score <10
Active medical disorder that could preclude participation in this protocol
Hypersensitivity to the radioligand or iodine
Myocardial infarction or cerebral infarct over preceding year, stable or unstable angina, known symptomatic coronary artery disease
Renal disease viewed by the physician to be too severe to warrant myocardial 123I-MIBG scintigraphy imaging
History of significant alcohol or drug abuse
Any other medical disorder considered by the study physicians as inappropriate for enrollment in this protocol
Patient or caregiver unwilling or unable to participate in all study-related procedures
Caregiver is not with a patient with dementia or severe parkinsonism at least 4 hours/day for at least 5 days/week
Patient or caregiver unwilling or unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Boeve, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
MIBG in Aging and Neurologic Disorders
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