DaTSCAN Imaging for Neurodegenerative Disease

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Cocaine, Iodine, others

Disqualifiers: Pregnancy, Renal disease, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well a special brain scan, called DaTscan, can help understand various brain conditions like Parkinson's, Alzheimer's, and REM sleep behavior disorder. The scan uses an injection of I-123 Ioflupane solution and a special imaging technique called single photon emission computed tomography (SPECT) to provide detailed pictures of brain activity. The researchers aim to determine if this scan can improve diagnosis and treatment plans for these neurodegenerative conditions. Suitable participants have a diagnosed condition like Parkinson's, Alzheimer's, or REM sleep disorder and are on a stable medication regimen. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved DaTscan can benefit more patients.

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 is the safety track record for these treatments?

Research has shown that Ioflupane I-123, used in DaTscan, is generally safe. Safety tests did not identify any special risks. A review of ten clinical trials and 13 years of post-approval use found it to be well-tolerated.

SPECT scans, part of the DaTscan process, also have a good safety record. Most people do not experience major side effects. Some may encounter minor issues like bleeding or pain at the injection site, but these are rare.

Overall, both DaTscan and SPECT scans are considered safe based on available evidence. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about DaTSCAN imaging because it offers a new way to visualize brain changes linked to neurodegenerative diseases. Unlike traditional methods that focus on symptoms or cognitive tests, DaTSCAN uses the I-123 Ioflupane solution to target dopamine transporters, giving a clearer picture of what's happening in the brain. This SPECT scan technique could potentially help doctors differentiate between conditions like Parkinson's Disease, Essential Tremor, and Alzheimer's Disease more accurately and earlier in the disease process. Early and precise diagnosis can lead to better tailored treatments for patients, which is why this trial is generating so much interest.

What evidence suggests that DaTscan imaging could be effective for neurodegenerative diseases?

Research has shown that DaTscan, which uses a special imaging agent called I-123 Ioflupane in SPECT scans, aids in diagnosing Parkinson's disease by highlighting changes in the brain's dopamine system. In this trial, participants with Parkinson's disease will undergo this imaging. Studies have also found it useful for diagnosing dementia with Lewy bodies, making it easier to distinguish from Alzheimer's disease. Participants with these conditions will also be evaluated using DaTscan. In cases of movement disorders or dementia, I-123 Ioflupane imaging improves diagnostic accuracy. This imaging technology reveals the brain areas affected by these conditions, helping doctors make more precise diagnoses. While data is limited for some conditions like mild cognitive impairment and corticobasal degeneration, DaTscan has a proven track record for Parkinson's and similar diseases. Participants with these conditions will also be part of this trial to further evaluate DaTscan's effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Bradley Boeve, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01453127

DaTSCAN Imaging in Aging and Neurodegenerative Disease One biomarker which is both highly sensitive and specific for evolving LBD in the setting of dementia is DaTscan [Ioflupane (123I)] imaging, in which loss of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11073567/

Practical use of DAT SPECT imaging in diagnosing ... 123 I-ioflupane SPECT Imaging is indicated for DLB diagnosis and differential diagnosis of Alzheimer's Disease, particularly in uncertain cases.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4091455/

Is ioflupane I123 injection diagnostically effective in ... Ioflupane (123 I) imaging has the potential to improve diagnostic accuracy in patients with signs and symptoms of a movement disorder and/or dementia.

4. withpower.com withpower.com/trial/phase-4-neurodegenerative-diseases-9-2011-01b11

DaTSCAN Imaging for Neurodegenerative Disease Research shows that I-123 Ioflupane solution injection, used in SPECT scans, helps accurately diagnose conditions like Parkinson's disease by highlighting ...

5. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rg.230133

Practical Overview of 123I-Ioflupane Imaging in ... This imaging assessment, which uses iodine 123 ( 123 I) ioflupane, can be useful to differentiate parkinsonian syndromes caused by nigrostriatal degeneration.

6. curiumpharma.com curiumpharma.com/wp-content/uploads/2020/08/SDS-US-Ioflupane-I-123-injection-final.pdf

SDS-US-Ioflupane-I-123-injection- ... Prolonged skin contact may cause temporary irritation. Skin corrosion/irritation. Ioflupane I-123 injection. SDS US. 958988 Version #: 01 ...

7. ema.europa.eu ema.europa.eu/en/documents/product-information/datscan-epar-product-information_en.pdf

DaTSCAN, Ioflupane (I-123) - European Medicines Agency 5.3 Preclinical safety data. Non-clinical data for ioflupane reveal no special hazard for humans based on conventional studies of safety pharmacology, single ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2011/022454Orig1s000Lbl.pdf

DaTscan (Ioflupane I 123 Injection) for Intravenous Use, CII Ioflupane I 123 Injection is a Schedule II controlled substance under the Controlled Substances Act. A DEA license is required for handling or administering ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/ioflupane-i-123-intravenous-route/description/drg-20074736

Ioflupane i 123 (intravenous route) - Side effects & uses This medicine helps to determine if you have symptoms (tremors) that are caused by Parkinsonian syndromes or dementia with Lewy bodies.

10. jnm.snmjournals.org jnm.snmjournals.org/content/55/8/1281

Safety Analysis of 10 Clinical Trials and for 13 Years After First ... Safety Analysis of 10 Clinical Trials and for 13 Years After First Approval of Ioflupane 123I Injection (DaTscan). Donald G. Grosset, Klaus ...