Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05514106
Other study ID # 21-012740
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date May 8, 2023
Est. completion date September 2025

Study information

Verified date June 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 90 Years
Eligibility 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

Study Design


Intervention

Drug:
meta-iodobenzylguanidine (MIBG) (123I)
1 administration of 123I-MIBG for a single SPECT scan
Diagnostic Test:
123I-MIBG scintigraphy
SPECT scan involving 123I-MIBG as the ligand

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlate myocardial 123I-MIBG scintigraphy findings Number of myocardial 123I-MIBG scintigraphy findings to correlate with clinical pathologic diagnosis 10 years
See also
  Status Clinical Trial Phase
Completed NCT05686486 - Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes N/A
Terminated NCT05451693 - Outreach-ER: A Dementia Care Intervention Program
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Enrolling by invitation NCT06040294 - Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills N/A
Completed NCT05114187 - An Internet-Based Education Program for Care Partners of People Living With Dementia N/A
Recruiting NCT06322121 - Vascular Aspects in Dementia: Part 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT04426838 - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad N/A
Recruiting NCT03462485 - Pilot Study of the Effects of Playing Golf on People With Dementia N/A
Active, not recruiting NCT03677284 - Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia N/A
Completed NCT03849937 - Changing Talk Online (CHATO) Study N/A
Recruiting NCT06284213 - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting NCT05579236 - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Completed NCT04571697 - A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
Completed NCT03583879 - Using Gait Robotics to Improve Symptoms of Parkinson's Disease N/A
Recruiting NCT06033066 - Financial Incentives and Recruitment to the APT Webstudy N/A
Active, not recruiting NCT05204940 - Longitudinal Observational Biomarker Study
Recruiting NCT05684783 - Dementia Champions in Homecare
Completed NCT03147222 - Function Focused Care: Fracture Care at Home N/A