Automated Imaging Differentiation of Parkinsonism

Parkinson Disease Clinical Trial

— AIDP  

Official title:

Automated Imaging Differentiation of Parkinsonism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913687
• Other study ID #: IRB202002350
• Secondary ID: PRO000283495U01N
• Status: Recruiting
• Start date: July 22, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: David Vaillancourt, PhD
• Phone: 352-294-1770
• Email: vcourt[@]ufl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to test the performance of the AID-P across 21 sites in the Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. The clinical diagnosis will be blinded to the diagnostic algorithm and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

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

• MSAp diagnosis

• PSP diagnosis

Exclusion Criteria:

• metal implants in the body that preclude an MRI (pacemaker, metallic clip, neurostimulator, etc)

• claustrophobia

• pregnancy

Related Conditions & MeSH terms

• Multiple System Atrophy
• Parkinson Disease
• Parkinsonian Disorders
• Progressive Supranuclear Palsy
• Shy-Drager Syndrome
• Supranuclear Palsy, Progressive

Intervention

Diagnostic Test:
• AIDP
Machine learning algorithm of imaging data

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa
Canada	Centre for Addiction and Mental Health	Toronto
United States	Albany Medical College	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	Augusta University	Augusta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Charlestown	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Pennsylvania State University	Hershey	Pennsylvania
United States	University of California San Diego	La Jolla	California
United States	University of Kentucky	Lexington	Kentucky
United States	Johns Hopkins University	Lutherville	Maryland
United States	University of Minnesota	Minneapolis	Minnesota
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	University of California San Francisco	San Francisco	California
United States	University of South Florida	Tampa	Florida
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (22)

Lead Sponsor

Collaborator

University of Florida

Albany Medical College, Augusta University, Beth Israel Deaconess Medical Center, Centre for Addiction and Mental Health, Duke University, Johns Hopkins University, Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS), Northwestern University, Ottawa Hospital Research Institute, Penn State University, University of Alabama at Birmingham, University of California, San Diego, University of California, San Francisco, University of Chicago, University of Kentucky, University of Michigan, University of Minnesota, University of South Florida, Wake Forest University, Washington University School of Medicine

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predicted diagnosis accuracy	utilizing the automated imaging differentiation of Parkinsonism (AIDP) tool to predict diagnosis compared to the expertise of two movement disorder specialists	12-18 months