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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
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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