DaTSCAN Imaging in Aging and Neurodegenerative Disease
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 11-001999
NCT ID: NCT01453127
Sponsor Protocol Number: 11-001999
About this study
The investigators propose using DaTscan in patients with mild cognitive impairment (MCI), Parkinson's disease (PD), dementia with Lewy bodies (DLB), Alzheimer's disease (AD), and other neurodegenerative syndromes and disorders, to test several hypotheses - some confirmatory, and some novel. Such use will provide new data on the potential clinical and research utility of DaTscan in neurodegenerative diseases. The findings on DaTscan will be correlated with clinical diagnoses and other multimodal imaging studies (e.g., MRI, MRS, FDG-PET, and amyloid-PET) to enhance our understanding of neurodegenerative diseases.
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. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
This study is enrolling participants by invitation only.
- 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.
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.