AIDP: Automated Imaging Differentiation of Parkinsonism

• Sponsor: University of Florida (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05913687
• Collaborator: Augusta University (Other), Albany Medical College (Other), Beth Israel Deaconess Medical Center (Other), Duke University (Other), Johns Hopkins University (Other), Massachusetts General Hospital (Other), Northwestern University (Other), Ottawa Hospital Research Institute (Other), Penn State University (Other), University of Alabama at Birmingham (Other), University of California, San Diego (Other), University of California, San Francisco (Other), University of Chicago (Other), University of Michigan (Other), University of Minnesota (Other), University of South Florida (Other), Centre for Addiction and Mental Health (Other), Wake Forest University (Other), Washington University School of Medicine (Other), University of Kentucky (Other), National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
• Enrollment: 315
• Locations: 21
• Anticipated Duration (Months): 56.3
• Patients Per Site: 15
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Multiple System Atrophy, Parkinson Variant; Progressive Supranuclear Palsy	Diagnostic Test: AIDP

Study Design

• Study Type: Observational
• Anticipated Enrollment: 315 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Automated Imaging Differentiation of Parkinsonism
• Actual Study Start Date: Jul 22, 2021
• Anticipated Primary Completion Date: Mar 31, 2026
• Anticipated Study Completion Date: Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Parkinson's disease Clinically diagnosed Parkinson's disease	Diagnostic Test: AIDP; Machine learning algorithm of imaging data
Multiple System Atrophy, Parkinsonian variant Clinically diagnosed Multiple System Atrophy, Parkinsonian variant	Diagnostic Test: AIDP; Machine learning algorithm of imaging data
Progressive Supranuclear Palsy Clinically diagnosed Progressive Supranuclear Palsy	Diagnostic Test: AIDP; Machine learning algorithm of imaging data

Outcome Measures

Primary Outcome Measures

1. Predicted diagnosis accuracy [12-18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of California San Diego	La Jolla	California	United States	92037
3	University of California San Francisco	San Francisco	California	United States	94158
4	University of Florida	Gainesville	Florida	United States	32611
5	University of South Florida	Tampa	Florida	United States	33613
6	Augusta University	Augusta	Georgia	United States	30912
7	Northwestern University	Chicago	Illinois	United States	60611
8	University of Chicago	Chicago	Illinois	United States	60637
9	University of Kentucky	Lexington	Kentucky	United States	40536
10	Johns Hopkins University	Lutherville	Maryland	United States	21093
11	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
12	Massachusetts General Hospital	Charlestown	Massachusetts	United States	02129
13	University of Michigan	Ann Arbor	Michigan	United States	48106
14	University of Minnesota	Minneapolis	Minnesota	United States	55414
15	Washington University in St. Louis	Saint Louis	Missouri	United States	63110
16	Albany Medical College	Albany	New York	United States	12020
17	Duke University Medical Center	Durham	North Carolina	United States	22705
18	Wake Forest University	Winston-Salem	North Carolina	United States	27157
19	Pennsylvania State University	Hershey	Pennsylvania	United States	17033
20	Ottawa Hospital Research Institute	Ottawa		Canada	K1Y 4E9
21	Centre for Addiction and Mental Health	Toronto		Canada	M5T 2S8

Sponsors and Collaborators

• University of Florida
• Augusta University
• Albany Medical College
• Beth Israel Deaconess Medical Center
• Duke University
• Johns Hopkins University
• Massachusetts General Hospital
• 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 Michigan
• University of Minnesota
• University of South Florida
• Centre for Addiction and Mental Health
• Wake Forest University
• Washington University School of Medicine
• University of Kentucky
• National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT05913687
• Other Study ID Numbers: IRB202002350; PRO00028349; 5U01NS119562
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Supranuclear Palsy, Progressive; Parkinsonian Disorders

Study Results

No Results Posted as of Jun 22, 2023