Trial · NCT02789020

Image Parkinson's Disease Progression Study

NCT02789020, Phase 2, Completed, University of Florida; results first posted 2023-09-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Image Parkinson's Disease Progression Study. Trials, record NCT02789020. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02789020

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Image Parkinson's Disease Progression Study
NCT number: NCT02789020
Status: Completed
Phases: Phase 2
Enrollment: 96 participants, actual
Lead sponsor: University of Florida
Conditions: Parkinson's Disease
Interventions: Rasagiline, Placebo, Magnetic Resonance Imaging, functional Magnetic Resonance Imaging, Physical Function Performance Test
First posted: 2016-06-02
Last updated: 2023-09-06
Results first posted: 2023-09-06

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Free-water Accumulation in the Substantia Nigra	Baseline and one-year	12-month study in PD to watch the effect of an Monoamine Oxidase-B inhibitor on the progressive increase of free-water accumulation in the substantia nigra. Recently, free-water diffusion MRI analysis using a bi-tensor model was developed to explicitly estimate the contribution of freely diffusing water molecules within the voxel. This free-water measure is expected to increase with atrophy-based neurodegeneration. Since substantia nigra degeneration occurs mostly in the posterior region of the substantia nigra in PD (ie. ventrolateral tier), we tested the hypothesis that free-water would be elevated in the posterior substantia nigra of PD.
Primary	Change in Blood Oxygen Level-dependent(BOLD) Signal in the Posterior Putamen, M1, and Supplementary Motor Area(SMA).	Baseline and one-year	12-month study in PD to watch the effect of an MAO-B inhibitor on BOLD signal in the posterior putamen, M1, and SMA.
Secondary	Changes in Parkinson's Disease Motor Symptoms and Bradykinesia	Baseline and one-year	Motor testing batteries such as the Purdue Pegboard Test will be administered to measure changes in the progression of the PD motor symptoms and bradykinesia.
Secondary	Changes Between the Groups on fMRI	Changes from baseline to 1 year	Participants will use their hand to squeeze an MRI compatible grip force transducer in the MRI unit.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Free-water Accumulation in the Substantia Nigra	Baseline and one-year		arbitrary units (A.U.s)	MEAN
PRIMARY	Change in Blood Oxygen Level-dependent(BOLD) Signal in the Posterior Putamen, M1, and Supplementary Motor Area(SMA).	Baseline and one-year	The values below represent the BOLD signal in SMA.	arbitrary units (A.U.s)	MEAN
SECONDARY	Changes in Parkinson's Disease Motor Symptoms and Bradykinesia	Baseline and one-year		count of pegs	MEAN
SECONDARY	Changes Between the Groups on fMRI	Changes from baseline to 1 year		unitless	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Free-water Accumulation in the Substantia Nigra	Rasagiline	0.0009	Standard Deviation 0.01	arbitrary units (A.U.s)
Change in Free-water Accumulation in the Substantia Nigra	Placebo	0.0041	Standard Deviation 0.01	arbitrary units (A.U.s)
Change in Blood Oxygen Level-dependent(BOLD) Signal in the Posterior Putamen, M1, and Supplementary Motor Area(SMA).	Rasagiline	-0.054	Standard Deviation 0.315	arbitrary units (A.U.s)
Change in Blood Oxygen Level-dependent(BOLD) Signal in the Posterior Putamen, M1, and Supplementary Motor Area(SMA).	Placebo	-0.086	Standard Deviation 0.251	arbitrary units (A.U.s)
Changes in Parkinson's Disease Motor Symptoms and Bradykinesia	Rasagiline	1.04	Standard Deviation 3.15	count of pegs
Changes in Parkinson's Disease Motor Symptoms and Bradykinesia	Placebo	0.689	Standard Deviation 3.94	count of pegs
Changes Between the Groups on fMRI	Rasagiline	-0.054	Standard Deviation 0.315	unitless
Changes Between the Groups on fMRI	Placebo	-0.086	Standard Deviation 0.251	unitless

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Rasagiline	45
Overall Study	STARTED	Placebo	45
Overall Study	COMPLETED	Rasagiline	39
Overall Study	COMPLETED	Placebo	40
Overall Study	NOT COMPLETED	Rasagiline	6
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Orthostatic Hypotension	Vascular disorders	Rasagiline	1	45	1
other	Orthostatic Hypotension	Vascular disorders	Placebo	0	45	0
other	Weight Loss	Metabolism and nutrition disorders	Rasagiline	1	45	1
other	Weight Loss	Metabolism and nutrition disorders	Placebo	0	45	0
other	Hypersexuality	Social circumstances	Rasagiline	1	45	1
other	Hypersexuality	Social circumstances	Placebo	0	45	0
other	Headaches	Nervous system disorders	Rasagiline	1	45	1
other	Headaches	Nervous system disorders	Placebo	0	45	0
other	Falls	Musculoskeletal and connective tissue disorders	Rasagiline	1	45	1
other	Falls	Musculoskeletal and connective tissue disorders	Placebo	1	45	1

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rasagiline	0	45
Total, all-cause mortality	Placebo	0	45
Total, other adverse events	Rasagiline	12	45
Total, other adverse events	Placebo	9	45
Total, serious adverse events	Rasagiline	0	45
Total, serious adverse events	Placebo	0	45

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01NS052318	Scaling and Sequencing Motor Output in Humans: fMRI Study	VAILLANCOURT, DAVID E	UNIVERSITY OF FLORIDA	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2005 to 2020

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Rasagiline vs Placebo: deaths from any cause	Trial comparisons
Rasagiline vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02789020

GET https://conductscience.org/api/trials/v1/NCT02789020/events?page=2

API reference For AI assistants