DaTSCAN Imaging for Neurodegenerative Disease

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that your medication regimen has been stable for the previous four weeks, and you must not be taking certain medications that could affect the DaTscan results. It's best to discuss your current medications with the study team to see if any changes are needed.

What data supports the effectiveness of the drug I-123 Ioflupane solution injection for neurodegenerative diseases?

Research shows that I-123 Ioflupane solution injection, used in SPECT scans, helps accurately diagnose conditions like Parkinson's disease by highlighting changes in brain areas affected by these diseases. This can lead to better management and treatment decisions for patients with movement disorders or dementia. ^{1 2 3 4 5}

Is DaTSCAN (I-123 Ioflupane) safe for use in humans?

DaTSCAN has been evaluated for safety in 10 clinical trials and over 13 years of use. In these studies, 22% of participants experienced some side effects, with 4% possibly related to DaTSCAN, including headache, nausea, and dizziness. Serious side effects were rare, occurring in 4% of participants. ^{1 2 3 6 7}

How is the drug I-123 Ioflupane solution injection (DaTscan) unique for neurodegenerative disease?

I-123 Ioflupane solution injection (DaTscan) is unique because it uses a special imaging technique called SPECT (single photon emission computed tomography) to visualize dopamine transporters in the brain, helping doctors distinguish between different types of neurodegenerative diseases like Parkinson's. This is particularly useful when the diagnosis is uncertain, as it provides a clearer picture of whether there is a dopamine deficiency, which is a hallmark of certain conditions. ^{1 2 3 8 9}

Research Team

Bradley Boeve, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

You are not taking certain medications that could affect the results of the DaTscan.

You are between 40 and 90 years old.

You scored above 10 on the MMSE test.

Exclusion Criteria

You are younger than 40 or older than 90 years old.

You scored less than 10 on the MMSE test.

Women with intact uterus and not post-menopausal unless pregnancy test performed at screening is negative

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

DaTscan Imaging

Participants undergo DaTscan imaging to assess dopaminergic neuron terminals in the striatum

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after DaTscan imaging

1-3 days

1 visit (in-person)

Long-term Follow-up

A subset of subjects will undergo a second DaTscan at least 1 year after the initial scan to assess changes over time

1 year

Treatment Details

Interventions

• I-123 Ioflupane solution injection
• Single photon emission computed tomography (SPECT) scan

Trial Overview 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.

Participant Groups

Group I: REM sleep behavior disorder Experimental Treatment 2 Interventions

REM sleep behavior disorder

Group II: Parkinson's Disease Experimental Treatment 2 Interventions

Parkinson's Disease

Group III: Mild Cognitive Impairment Experimental Treatment 2 Interventions

Mild Cognitive Impairment

Group IV: Frontotemporal Dementia Experimental Treatment 2 Interventions

Frontotemporal Dementia

Group V: Essential Tremor Experimental Treatment 2 Interventions

Essential Tremor

Group VI: Dementia with Lewy Bodies Experimental Treatment 2 Interventions

Dementia with Lewy Bodies

Group VII: Corticobasal Degeneration Experimental Treatment 2 Interventions

Corticobasal Degeneration

Group VIII: Alzheimer's Disease Experimental Treatment 2 Interventions

Alzheimer's Disease

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Association between Hoehn and Yahr, Mini-Mental State Examination, age, and clinical syndrome predominance and diagnostic effectiveness of ioflupane I 123 injection (DaTSCAN™) in subjects with clinically uncertain parkinsonian syndromes. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Individual-reader diagnostic performance and between-reader agreement in assessment of subjects with Parkinsonian syndrome or dementia using 123I-ioflupane injection (DaTscan) imaging. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Is ioflupane I123 injection diagnostically effective in patients with movement disorders and dementia? Pooled analysis of four clinical trials. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Optimizing the Diagnosis of Parkinsonian Syndromes With 123I-Ioflupane Brain SPECT. [2020]

5. Greece pubmed.ncbi.nlm.nih.gov

The brain scintiscan with iodine-123-ioflupane to diagnose early Parkinson's disease; seven months follow up. First results in Bulgaria. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Safety analysis of 10 clinical trials and for 13 years after first approval of ioflupane 123I injection (DaTscan). [2017]

7. England pubmed.ncbi.nlm.nih.gov

DaTSCAN® dilution with 0.9% NaCl - A stability evaluation. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Clinical utility of DaTscan™ imaging in the evaluation of patients with parkinsonism: a US perspective. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Effective and efficient diagnosis of parkinsonism: the role of dopamine transporter SPECT imaging with ioflupane I-123 injection (DaTscan™). [2017]