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Search / Trial NCT01453127

DaTSCAN Imaging in Aging and Neurodegenerative Disease

Launched by MAYO CLINIC · Oct 12, 2011

Trial Information

Current as of May 04, 2025

Enrolling by invitation

Keywords

Dementia Parkinsonism Mild Cognitive Impairment Rem Sleep Behavior Disorder

ClinConnect Summary

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 phenotypic variability of LBD is striking, as it can manifest as the well-known disorder of Parkinson's disease without (PD) and with dementia (PDD), as well as DLB, MCI, REM sleep behavior disorder (RBD), pure autonomic failure (PAF), and other syndromes.

One biomarker which is both highly sensitive and specific for evolving LBD in the setting of dementia is DaTscan \[Ioflupane (123I)\] imaging, in which ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Diagnosis of one of the syndromes of interest using established criteria
  • Age 40-90 inclusive
  • MMSE 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 DaTscan 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
  • 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
  • MMSE score \<10
  • Active medical disorder that could preclude participation in this protocol
  • Hypersensitivity to the radioligand, cocaine, or iodine (including seafood allergy)
  • Myocardial infarction or cerebral infarct over preceding year, stable or unstable angina, known symptomatic coronary artery disease
  • Renal or liver disease viewed by the physician to be too severe to warrant DaTscan infusion/imaging
  • History of significant alcohol or drug abuse
  • Any other medical disorder considered by the study physicians as inappropriate for 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

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Bradley Boeve, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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