Utility of MIBG Scintigraphy in Aging and Neurodegenerative Disease

Overview

About this study

The objective of the study is to use myocardial 123I-MIBG scintigraphy along with other clinical, neuropsychological, and neuroimaging findings to identify which patients with the following syndromes/diagnoses/features who have probable underlying Lewy Body Disease:

  • dementia;
  • parkinsonism;
  • mild cognitive impairment;
  • REM sleep behavior disorder;
  • REM sleep without atonia, as well as in those with normal neurologic functioning.

This is an open-label study using a radioligand and SPECT scan. The safety results will be presented using descriptive statistics. Qualitative assessments of the extent and intensity of the heart to mediastinum (H/M) ratio, and quantitative assessments (median and distributions of H/M ratio) for the various syndromes and disorders will be compared to normal controls, and between the various syndromes/disorders.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Diagnosis of one of one of the syndromes/diagnoses of interest using established criteria.
  • Age ≥ 40 to ≤ 90 inclusive.
  • 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.
  • For those with dementia, caregiver that is with the patient at least four hours/day for at least five 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 apropriate, has caregiver capable of giving consent on the subject's behalf.

Exclusion Criteria:

  • Does not fulfill criteria for any of the desired diagnoses.
  • Age > 40 or < 90.
  • 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.

Eligibility last updated 1/4/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bradley Boeve, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Elizabeth Abrahamson

(507) 422-9792

Abrahamson.Elizabeth@mayo.edu

More information

Publications

Publications are currently not available