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Radiopharmaceutical
DaTSCAN Imaging for Neurodegenerative Disease
Phase 4
Waitlist Available
Led By Bradley Boeve, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will be followed to 1-3 days after scan.
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial will test whether the DaTscan can help doctors better understand and diagnose neurodegenerative diseases.
Who is the study for?
This trial is for adults aged 40-90 with conditions like Parkinson's, various dementias, or mild cognitive impairment. Participants need a Mini-Mental State Exam (MMSE) score over 10 and can't be on certain meds that affect the test results. Those with dementia must have a caregiver present regularly.
What is being tested?
The study tests DaTscan imaging in patients with neurodegenerative diseases by injecting I-123 Ioflupane before a SPECT scan. It aims to correlate these scans with clinical diagnoses and other brain imaging techniques to better understand these conditions.
What are the potential side effects?
Potential side effects may include allergic reactions related to iodine or the radioligand used in DaTscan, similar to those who might react to seafood allergies. The procedure itself is generally safe but consult your doctor about specific risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ participants will be followed for 1-3 days after scan.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be followed for 1-3 days after scan.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Correlate the DaTscan findings with clinical diagnosis
Secondary study objectives
Safety of DaTscan imaging
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: REM sleep behavior disorderExperimental Treatment2 Interventions
REM sleep behavior disorder
Group II: Parkinson's DiseaseExperimental Treatment2 Interventions
Parkinson's Disease
Group III: Mild Cognitive ImpairmentExperimental Treatment2 Interventions
Mild Cognitive Impairment
Group IV: Frontotemporal DementiaExperimental Treatment2 Interventions
Frontotemporal Dementia
Group V: Essential TremorExperimental Treatment2 Interventions
Essential Tremor
Group VI: Dementia with Lewy BodiesExperimental Treatment2 Interventions
Dementia with Lewy Bodies
Group VII: Corticobasal DegenerationExperimental Treatment2 Interventions
Corticobasal Degeneration
Group VIII: Alzheimer's DiseaseExperimental Treatment2 Interventions
Alzheimer's Disease
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,337 Previous Clinical Trials
3,060,674 Total Patients Enrolled
Bradley Boeve, MDPrincipal InvestigatorMayo Clinic
5 Previous Clinical Trials
3,390 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not taking certain medications that could affect the results of the DaTscan.You are younger than 40 or older than 90 years old.You scored less than 10 on the MMSE test.You are allergic to the radioligand, cocaine, or iodine, including seafood.You have had a heart attack or stroke in the past year, or have known heart disease that causes chest pain.Your kidney or liver disease is too severe for the DaTscan infusion/imaging, according to the doctor.You have a history of heavy drinking or drug abuse.The study doctors think your medical condition is not right for this study.You do not have any of the specific medical conditions needed for this study.You are between 40 and 90 years old.You scored above 10 on the MMSE test.If you have dementia, your caregiver must be with you for at least 4 hours a day, 5 days a week.You have been diagnosed with one of the specific syndromes using well-known criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Dementia with Lewy Bodies
- Group 2: Parkinson's Disease
- Group 3: Essential Tremor
- Group 4: Mild Cognitive Impairment
- Group 5: REM sleep behavior disorder
- Group 6: Frontotemporal Dementia
- Group 7: Alzheimer's Disease
- Group 8: Corticobasal Degeneration
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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