Parkinson DiseaseAIDPNCT05913687
Automated Imaging Differentiation of Parkinsonism
An observational study of Parkinson Disease and Multiple System Atrophy, Parkinson Variant, run by University of Florida at 21 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease, Multiple System Atrophy, Parkinson Variant, Progressive Supranuclear Palsy
- What is being tested?
- AIDP
- How many people
- 315 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 22 Jul 2021to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults between the ages of 40 and 80 who meet one of the three diagnoses: PD, MSAp, or PSP *As of 11/9/23, we have filled the cohorts for both PD and PSP patients. We are only enrolling MSAp patients at this time.
Who may be able to join
- Parkinson's disease diagnosis within 5-9 years of baseline date
- MSAp diagnosis
- PSP diagnosis
Who cannot join
- metal implants in the body that preclude an MRI (pacemaker, metallic clip, neurostimulator, etc)
- claustrophobia
- pregnancy
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
Albany Medical College
Albany, New York, 12020
University of Michigan
Ann Arbor, Michigan, 48106
Augusta University
Augusta, Georgia, 30912
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Duke University Medical Center
Durham, North Carolina, 22705
University of Florida
Gainesville, Florida, 32611
Pennsylvania State University
Hershey, Pennsylvania, 17033
University of California San Diego
La Jolla, California, 92037
University of Kentucky
Lexington, Kentucky, 40536
Johns Hopkins University
Lutherville, Maryland, 21093
University of Minnesota
Minneapolis, Minnesota, 55414
University of California San Francisco
San Francisco, California, 94158
Washington University in St. Louis
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33613
Wake Forest University
Winston-Salem, North Carolina, 27157
Canada2 sites
Ottawa Hospital Research Institute
Ottawa, K1Y 4E9
Centre for Addiction and Mental Health
Toronto, M5T 2S8
About this study
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.
- Conditions
- Parkinson Disease, Multiple System Atrophy, Parkinson Variant, Progressive Supranuclear Palsy
- Being tested
- AIDP
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIDPDiagnostic test
Machine learning algorithm of imaging data
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | Clinically diagnosed Parkinson's disease Receives: Diagnostic Test: AIDP | |
| Multiple System Atrophy, Parkinsonian variant | Clinically diagnosed Multiple System Atrophy, Parkinsonian variant Receives: Diagnostic Test: AIDP | |
| Progressive Supranuclear Palsy | Clinically diagnosed Progressive Supranuclear Palsy Receives: Diagnostic Test: AIDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicted diagnosis accuracy
utilizing the automated imaging differentiation of Parkinsonism (AIDP) tool to predict diagnosis compared to the expertise of two movement disorder specialists
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start22 Jul 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- 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)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913687
- Sponsor's protocol ID
- IRB202002350
- Other IDs
- PRO00028349, 5U01NS119562
- Acronym
- AIDP
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Imaging Differentiation of Parkinsonism
- ClinicalTrials.gov ID
- NCT05913687
- Acronym / sponsor ID
- AIDP / IRB202002350
- Conditions
- Parkinson Disease, Multiple System Atrophy, Parkinson Variant, Progressive Supranuclear Palsy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- 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)
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | – | Diagnostic Test: AIDPClinically diagnosed Parkinson's disease |
| Multiple System Atrophy, Parkinsonian variant | – | Diagnostic Test: AIDPClinically diagnosed Multiple System Atrophy, Parkinsonian variant |
| Progressive Supranuclear Palsy | – | Diagnostic Test: AIDPClinically diagnosed Progressive Supranuclear Palsy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults between the ages of 40 and 80 who meet one of the three diagnoses: PD, MSAp, or PSP *As of 11/9/23, we have filled the cohorts for both PD and PSP patients. We are only enrolling MSAp patients at this time.
Key inclusion criteria (3 listed)
- Parkinson's disease diagnosis within 5-9 years of baseline date
- MSAp diagnosis
- PSP diagnosis
Key exclusion criteria (3 listed)
- metal implants in the body that preclude an MRI (pacemaker, metallic clip, neurostimulator, etc)
- claustrophobia
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIDPMachine learning algorithm of imaging data | Diagnostic test | Multiple System Atrophy, Parkinsonian variant, Parkinson's disease, Progressive Supranuclear Palsy |
Primary outcome
Predicted diagnosis accuracy
Time frame: 12-18 months
utilizing the automated imaging differentiation of Parkinsonism (AIDP) tool to predict diagnosis compared to the expertise of two movement disorder specialists
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Multiple System Atrophy, Parkinson Variant, run by University of Florida at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicted diagnosis accuracy (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.