DaTSCAN Imaging in Aging and Neurodegenerative Disease (NCT01453127) | Clinical Trial Compass
By InvitationPhase 4
DaTSCAN Imaging in Aging and Neurodegenerative Disease
United States500 participantsStarted 2011-10
Plain-language 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 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.
Who can participate
Age range
40 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 consi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlate the DaTscan findings with clinical diagnosis
Timeframe: Participants will be followed to 1-3 days after scan.