Status:
ENROLLING_BY_INVITATION
DaTSCAN Imaging in Aging and Neurodegenerative Disease
Lead Sponsor:
Mayo Clinic
Conditions:
Dementia
Parkinsonism
Eligibility:
All Genders
40-90 years
Phase:
PHASE4
Brief Summary
The investigators propose using DaTscan in patients with REM sleep behavior disorder (RBD), mild cognitive impairment (MCI), Parkinson's disease (PD), dementia with Lewy bodies (DLB), Alzheimer's dise...
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 phenotypic va...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01453127
Start Date
October 1 2011
End Date
December 1 2025
Last Update
March 25 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905