What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as levodopa and dopamine agonists, often come with side effects. Levodopa can cause nausea, somnolence, dizziness, headache, confusion, hallucinations, delusions, agitation, psychosis, and orthostatic hypotension. Dopamine agonists may lead to similar side effects, including impulse control disorders. Other treatments like MAO B inhibitors and COMT inhibitors can also cause gastrointestinal issues and orthostatic hypotension. These side effects generally require careful dose adjustments and monitoring by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Parkinson's Disease, focusing on different mechanisms of action. For imaging purposes similar to Altropane, which binds to dopamine transporters, there are no direct equivalents mentioned. However, for symptomatic treatment, the FDA has approved dopamine agonists such as pramipexole and ropinirole, as well as MAO-B inhibitors like selegiline and rasagiline. Levodopa, often combined with carbidopa, remains the cornerstone of Parkinson's treatment. Additionally, newer VMAT2 inhibitors like deutetrabenazine and valbenazine have been approved for related movement disorders, though not specifically for Parkinson's.

What other types of research exist?

Promising novel alternatives to Altropane for imaging in Parkinson's Disease patients include [18F]Dopa PET, [123I]beta-CIT, [11C]raclopride, and ONO-2160/carbidopa. These agents and techniques have shown efficacy in recent studies and may offer improved imaging precision and patient outcomes.

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Altropane Imaging for Parkinson's Disease

Phase 2

Recruiting

Research Sponsored by GE Healthcare

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 baseline (pre-altropane) and within 60 minutes after imaging.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a lower dose of Altropane (5 millicuries) can be used for brain imaging in patients suspected of having Parkinson's disease. Altropane helps doctors see specific areas of the brain more clearly on scans. The goal is to determine if a smaller amount can still provide clear images. Altropane is a special substance used in brain imaging to help visualize specific areas, particularly in diagnosing Parkinson's disease.

Who is the study for?

This trial is for adults who suspect they have Parkinson's disease. Participants must be willing to follow study rules and use effective birth control if of childbearing potential. They should not have thyroid diseases, cognitive impairments, or recent drug/alcohol abuse, and cannot be pregnant or breastfeeding.

What is being tested?

The study tests whether a lower dose (5 millicuries) of Altropane is effective for imaging in suspected Parkinson's patients compared to the previously used higher dose (8 millicuries).

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to the injection such as pain at the injection site, allergic reactions to Altropane ingredients, or issues from lying supine during imaging.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-altropane) and within 60 minutes after imaging.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-altropane) and within 60 minutes after imaging.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-altropane) and within 60 minutes after imaging. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Striatal uptake

Secondary study objectives

Inter-reader agreement

Number of participants with abnormal body temperature (degrees Celsius).

Number of participants with abnormal electrocardiogram (ECG) examinations (PR interval, QTc, QRS and RR interval).

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Altropane (123I) InjectionExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease (PD) primarily aim to manage motor symptoms by enhancing dopaminergic activity in the brain. Levodopa, often combined with carbidopa, is converted to dopamine in the brain, replenishing the diminished dopamine levels characteristic of PD. Dopamine agonists mimic dopamine by stimulating dopamine receptors directly. Monoamine oxidase B (MAO-B) inhibitors prevent the breakdown of dopamine, thereby increasing its availability. Catechol-O-methyl transferase (COMT) inhibitors extend the effect of levodopa by inhibiting its breakdown. These treatments are crucial for PD patients as they help alleviate motor symptoms such as tremors, rigidity, and bradykinesia, thereby improving quality of life. Understanding and targeting the dopaminergic system, as seen with imaging agents like Altropane, is essential for both diagnosis and effective management of PD.

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