Automated Imaging for Parkinsonism

(AIDP Trial)

Not currently recruiting at 21 trial locations

Overseen By David Vaillancourt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Metal implants, Claustrophobia, Pregnancy

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test new software that helps doctors better understand different types of parkinsonism through brain images. It will compare the software's findings with expert doctors' opinions to evaluate its effectiveness. The trial involves individuals with Parkinson's disease, Multiple System Atrophy (a condition similar to Parkinson’s), and Progressive Supranuclear Palsy (a rare brain disorder). Those who have had Parkinson's disease for 5 to 9 years and can undergo an MRI (a type of body scan) might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance diagnostic tools for parkinsonism.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the AID-P is safe for use in diagnosing Parkinson's disease and related disorders?

Research shows that the AIDP tool in this trial is designed to help diagnose Parkinson's disease and similar conditions. It is important to note that AIDP is not a medical treatment or drug, so it does not carry the same risks. Instead, it is a software tool used for imaging and diagnosis.

The safety of this tool concerns how it manages data and whether it provides accurate and reliable results, rather than causing side effects like a drug might. Since this trial uses a software tool and not medication, there are no known health risks for participants. The focus is on how well the tool can identify and differentiate between conditions such as Parkinson's disease, multiple system atrophy, and progressive supranuclear palsy.

Participants can be assured that joining this trial does not involve medical risks related to treatment side effects. The main goal is to evaluate how well the software aids doctors in making accurate diagnoses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how we differentiate between types of parkinsonism using automated imaging. Unlike traditional methods that rely heavily on clinical assessments and symptoms, this technique uses advanced imaging technology to provide clearer, more accurate distinctions between conditions like Parkinson's disease, Multiple System Atrophy, and Progressive Supranuclear Palsy. This could lead to quicker, more accurate diagnoses and tailored treatments for patients, potentially improving outcomes and quality of life.

What evidence suggests that the AID-P is effective for diagnosing Parkinson's disease?

Research has shown that the Automated Imaging Differentiation of Parkinsonism (AIDP) tool can differentiate between various movement disorders. In a study involving 1,002 participants, AIDP successfully distinguished between healthy individuals and those with Parkinson's disease, multiple system atrophy, and progressive supranuclear palsy. Among the participants, 51% had Parkinson's disease, while the others had related conditions. This trial will assess AIDP's effectiveness in distinguishing these conditions. The tool's success lies in its ability to compare imaging results with diagnoses made by neurologists specializing in movement disorders. This indicates that AIDP could accurately identify these conditions using imaging data. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

Parkinson's disease diagnosis within 5-9 years of baseline date

MSAp diagnosis

PSP diagnosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Diagnosis

Participants undergo imaging and clinical scales, and data is uploaded to the web-based software tool for analysis

12-18 months

Follow-up

Participants are monitored for safety and effectiveness after imaging and diagnosis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AIDP

How Is the Trial Designed?

Group I: Progressive Supranuclear Palsy Experimental Treatment 1 Intervention

Clinically diagnosed Progressive Supranuclear Palsy

Group II: Parkinson's disease Experimental Treatment 1 Intervention

Clinically diagnosed Parkinson's disease

Group III: Multiple System Atrophy, Parkinsonian variant Experimental Treatment 1 Intervention

Clinically diagnosed Multiple System Atrophy, Parkinsonian variant

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Penn State University

Collaborator

Trials

380

Recruited

131,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Augusta University

Collaborator

Trials

219

Recruited

85,900+

Albany Medical College

Collaborator

Trials

96

Recruited

12,700+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9759125/

Clinical outcomes and cognitive impairments between ... MSA‐P patients had a significantly higher incidence of dyskinesia, fall, urinary symptoms, and constipation, whereas patients with PSP had a ...

2. academic.oup.com academic.oup.com/braincomms/article/7/1/fcaf022/7958714

Biomarkers of disease progression in ... - Oxford Academic found that in PSP subjects with a short disease duration (13 months median) CSF NfL increased by 27.1% over 12 months, while it remained ...

3. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(19)30105-0/fulltext

Development and validation of the automated imaging ... 278 (28%) of these individuals were healthy controls, 511 (51%) had Parkinson's disease, 84 (8%) had multiple system atrophy, and 129 (13%) had ...

4. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mdc3.70338

Progressive Supranuclear Palsy—A Global Review Overall outcomes for PSP patients are generally poor; however, there are notable differences in survival rates and disease progression across ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1353802024010599

Multidisciplinary care use in neurodegenerative complex ... Multidisciplinary care use in neurodegenerative complex diseases: The example of progressive supranuclear palsy and advanced Parkinson's disease in real-life.

6. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/acute-inflammatory-demyelinating-polyneuropathy

Acute Inflammatory Demyelinating Polyneuropathy AIDP is a rapidly progressive peripheral neuropathy that may affect multiple organ systems. Although prognosis is usually good, this syndrome may result in life ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK563249/

Chronic Inflammatory Demyelinating Polyradiculoneuropathy Between 85% to 90% of patients with CIDP will have elevated protein and mild pleocytosis of fewer than 10 cells/mm³. A leukocyte count of more than 10 cells/mm³ ...

8. medlink.com medlink.com/articles/acute-inflammatory-demyelinating-polyradiculoneuropathy

Acute inflammatory demyelinating polyradiculoneuropathy Acute inflammatory demyelinating polyradiculoneuropathy is the most frequent pattern of Guillain-Barré syndrome encountered in North America and Europe.

9. now.aapmr.org now.aapmr.org/aidpcidp-part-2-treatment/

AIDP/CIDP Part 2: Treatment | PM&R KnowledgeNow Serious side effects are uncommon but may include hypotension or hypertension, bradycardia or tachycardia, immunosuppression, hypocalcemia, ...

10. hrsa.gov hrsa.gov/sites/default/files/hrsa/advisory-committees/vaccines/cdc-chronic-inflammatory.pdf

Chronic Inflammatory Demyelinating Polyneuropathy ( ... CIDP is a chronic, progressive nerve disease causing weakness, while GBS is an acute, monophasic illness also causing weakness.