DaTSCAN Imaging in Aging and Neurodegenerative Disease

Launched by MAYO CLINIC · Oct 12, 2011

Keywords

ClinConnect Summary

This clinical trial is studying how well a DaTscan, which uses a radioactive dye injected into a vein and a brain scan (SPECT), matches doctors’ diagnoses in people with REM sleep behavior disorder, mild cognitive impairment, Parkinson’s disease, dementia with Lewy bodies, Alzheimer’s disease, and related conditions. The researchers want to see if DaTscan findings can help confirm or refine diagnoses and how DaTscan might fit with other brain imaging tests. Some participants may have a second DaTscan about a year later to see if changes over time could provide any prognostic information. The main goal is to correlate scan results with clinical diagnoses; a secondary goal is to assess the safety and tolerability of the imaging procedure.

Who may be eligible and what to expect: adults aged 40–90 with one of the study conditions, or mild cognitive impairment, and with an MMSE score above 10, can participate if they have stable medications and no active medical issues that would prevent joining. Women who are pregnant or breast-feeding are not eligible. A caregiver must be involved for participants with dementia. The trial is non-randomized and involves about 500 participants in a single group, conducted at Mayo Clinic. Participants will receive the DaTscan procedure and may also have additional brain imaging tests as part of the study, with safety follow-up 1–3 days after the scan; some will have a second scan after at least a year. This is a research study to learn more about diagnosing neurodegenerative diseases, not a test of a treatment.

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