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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS052318 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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Parkinson's disease (PD) is a neurodegenerative brain disorder that impairs the ability to perform functions such as grooming, dressing, cooking, and other activities of daily living. PD affected between 4.1 and 4.6 million people worldwide in 2005, and it is projected that up to 9.3 million people will be affected by 2030. Although current pharmacological therapies provide beneficial effects on motor symptoms of the disease (tremor, rigidity, and bradykinesia), intolerable disability eventually develops in most patients. A disease-modifying therapy that slows disease progression is a major unmet medical need in PD. Numerous agents have neuroprotective effects in pre-clinical laboratory models, but none have been shown to have indisputable disease-modifying effects in clinical trials for patients with PD.
The purpose of this research study is to investigate how the brain and motor behavior changes in PD over time in response to rasagiline which is a monoamine oxidase-B(MAO-B) inhibitor. The drug rasagiline will be tested in this study as the MAO-B inhibitor. Rasagiline has been prescribed for many years to treat symptomatic Parkinson's disease. It is FDA approved for the treatment of Parkinson's disease but has not been shown to slow disease progression. The outcome and impact of this study will provide the first evaluation of MAO-B inhibitors at slowing the progression of the nigrostriatal pathway using advanced Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) methods in PD.
Participants will receive baseline testing to confirm a diagnosis of Parkinsonism and to determine eligibility in the research study. Half of the participants in this study will be in a group that will receive the study drug (rasagiline), and half will be in a group that will receive a placebo. A placebo is a pill that is made to look like the study drug, but it does not contain any active ingredients. A computer algorithm will randomly decide group assignment (like the flip of a coin). The study drug will be provided at the end of the first visit. The participants will not know which study drug is received, placebo or rasagiline.
During the research study the following test may occur: (1) questionnaires about quality of life and depression; (2) tests to measure strength and motor function; (3) tests to measure cognition; (4) orientation session to learn a precision gripping task; (5) functional MRI scan of the brain; (6) structural MRI scan of the brain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rasagiline | Experimental | This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale. |
|
| Placebo | Placebo Comparator | This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasagiline | Drug | Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Free-water Accumulation in the Substantia Nigra | 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. | Baseline and one-year |
| Change in Blood Oxygen Level-dependent(BOLD) Signal in the Posterior Putamen, M1, and Supplementary Motor Area(SMA). | 12-month study in PD to watch the effect of an MAO-B inhibitor on BOLD signal in the posterior putamen, M1, and SMA. | Baseline and one-year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Parkinson's Disease Motor Symptoms and Bradykinesia | 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. | Baseline and one-year |
| Changes Between the Groups on fMRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Vaillancourt, PhD. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for Rehabilitation Neuroscience | Gainesville | Florida | 32611 | United States |
Individual participant data will be available without any personal identifiers included.
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96 participants diagnosed with PD signed the informed consent document for the study. 6 of these individuals did not complete the study protocol for a variety of reasons: 1 person revealed he had a prior stroke so he was disqualified at the visit, 2 people were excluded due to space restrictions in the MRI, and 3 people withdrew due to claustrophobia related to the MRI. Therefore, out of the 96 people who signed the consent (were enrolled), only 90 peoples' data were included/randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rasagiline | This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale. Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain. Magnetic Resonance Imaging: This test will be performed at baseline and one year. functional Magnetic Resonance Imaging: This test will be performed at baseline and one year. Physical Function Performance Test: This test will be performed at baseline and one year. |
| FG001 | Placebo | This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale. Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention. Magnetic Resonance Imaging: This test will be performed at baseline and one year. functional Magnetic Resonance Imaging: This test will be performed at baseline and one year. Physical Function Performance Test: This test will be performed at baseline and one year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rasagiline | This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale. Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain. Magnetic Resonance Imaging: This test will be performed at baseline and one year. functional Magnetic Resonance Imaging: This test will be performed at baseline and one year. Physical Function Performance Test: This test will be performed at baseline and one year. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Free-water Accumulation in the Substantia Nigra | 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. | Posted | Mean | Standard Deviation | arbitrary units (A.U.s) | Baseline and one-year |
|
1 year (the follow-up occurred one year after the baseline visit)
Documented in a running table and submitted to University of Florida Institutional Review Board for acknowledgement
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rasagiline | This group will receive a 1 mg rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale. Rasagiline: Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain. Magnetic Resonance Imaging: This test will be performed at baseline and one year. functional Magnetic Resonance Imaging: This test will be performed at baseline and one year. Physical Function Performance Test: This test will be performed at baseline and one year. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orthostatic Hypotension | Vascular disorders | Non-systematic Assessment | Patient experienced low blood pressure while on medication, but was unsure if medication is the cause. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Vaillancourt | University of Florida | 3522941770 | vcourt@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2020 | Jun 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 30, 2020 | Jun 12, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C031967 | rasagiline |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Placebo | Other | A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention. |
|
| Magnetic Resonance Imaging | Device | This test will be performed at baseline and one year. |
|
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| functional Magnetic Resonance Imaging | Device | This test will be performed at baseline and one year. |
|
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| Physical Function Performance Test | Other | This test will be performed at baseline and one year. |
|
Participants will use their hand to squeeze an MRI compatible grip force transducer in the MRI unit. |
| Changes from baseline to 1 year |
| BG001 | Placebo | This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale. Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention. Magnetic Resonance Imaging: This test will be performed at baseline and one year. functional Magnetic Resonance Imaging: This test will be performed at baseline and one year. Physical Function Performance Test: This test will be performed at baseline and one year. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Montreal Cognitive Assessment | The MoCA is out of 30 and higher score indicates better cognitive ability. Scores of 24 or under indicate cognitive impairment. The minimum score is 0 and the maximum score is 30. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Rating Scale for Depression | The Hamilton Depression Scale is scored out of a total of 52. A higher score indicates the patient experiences more depression; scores about 17 are considered moderate to severe. The minimum score is 0 and the maximum score is 52. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Anxiety Rating Scale | The Hamilton Anxiety Scales is totaled out of 56. A higher score indicates more anxiety experienced by the patient; scores of 25-30 are considered moderate to severe. The minimum score is 0 and the maximum score is 56. | Mean | Standard Deviation | units on a scale |
|
| Parkinson's Disease Questionnaire (PDQ-39) | The PDQ-39 is scored out a total of 100. A higher score indicates that the patient experiences more deficits as a result of PD. The minimum score is 0 and the maximum score is 100. | Mean | Standard Deviation | units on a scale |
|
| Movement Disorders Society UPDRS | The max score of UPDRS is 199. A higher score indicates more deficits as a result of PD. The minimum score is 0 and the maximum score is 199. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Placebo | This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale. Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention. Magnetic Resonance Imaging: This test will be performed at baseline and one year. functional Magnetic Resonance Imaging: This test will be performed at baseline and one year. Physical Function Performance Test: This test will be performed at baseline and one year. |
|
|
| Primary | Change in Blood Oxygen Level-dependent(BOLD) Signal in the Posterior Putamen, M1, and Supplementary Motor Area(SMA). | 12-month study in PD to watch the effect of an MAO-B inhibitor on BOLD signal in the posterior putamen, M1, and SMA. | The values below represent the BOLD signal in SMA. | Posted | Mean | Standard Deviation | arbitrary units (A.U.s) | Baseline and one-year |
|
|
|
| Secondary | Changes in Parkinson's Disease Motor Symptoms and Bradykinesia | 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. | Posted | Mean | Standard Deviation | count of pegs | Baseline and one-year |
|
|
|
| Secondary | Changes Between the Groups on fMRI | Participants will use their hand to squeeze an MRI compatible grip force transducer in the MRI unit. | Posted | Mean | Standard Deviation | unitless | Changes from baseline to 1 year |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 12 |
| 45 |
| EG001 | Placebo | This group will receive a placebo tablet in the same forum as the rasagiline tablet to be taken once daily for one year. In addition, the following test will be performed: a Magnetic Resonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI), the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, Brief Test of Attention, Beck Depression Index, Hamilton Anxiety and Depression Rating Scales, Physical Function Performance Test, and Epworth Sleepiness Scale. Placebo: A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention. Magnetic Resonance Imaging: This test will be performed at baseline and one year. functional Magnetic Resonance Imaging: This test will be performed at baseline and one year. Physical Function Performance Test: This test will be performed at baseline and one year. | 0 | 45 | 0 | 45 | 9 | 45 |
|
| Weight Loss | Metabolism and nutrition disorders | Non-systematic Assessment | Patient experienced weight loss while on medication, but is unsure if medication was the cause. |
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| Hypersexuality | Social circumstances | Non-systematic Assessment | Patient experienced hypersexuality while on medication, but was unsure if medication is the cause. |
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| Headaches | Nervous system disorders | Non-systematic Assessment | Patient experienced headaches while on medication, but was unsure if medication was the cause. |
|
| Falls | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient experienced falls while on medication/placebo, but was unsure if medication was the cause. |
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| Hair Loss | Endocrine disorders | Non-systematic Assessment | Patient experienced hair loss while on medication, but was unsure if medication was the cause. |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Patient experienced vomiting while on the placebo, but there should be no connection to the placebo. |
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| Joint Pain/Stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patients experienced joint pain/stiffness while on medication/placebo, but was unsure if medication was the cause. |
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| Vertigo/Dizziness | Nervous system disorders | Non-systematic Assessment | Patient experienced vertigo/dizziness while on placebo, but there should be no connection to the placebo. |
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| Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient experienced congestion while on placebo, but there should be no connection to placebo. |
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| Edema | Vascular disorders | Non-systematic Assessment | Patient experienced edema while on placebo, but there should be no connection to placebo. |
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| Fatigue | Social circumstances | Non-systematic Assessment | Patients experienced fatigue while on medication/placebo, but was unsure if medication was the cause. |
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| Light-Headedness | Nervous system disorders | Non-systematic Assessment | Patient experienced light-headedness while on medication/placebo, but was unsure if medication was the cause. |
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| Increased Resting Tremor | Nervous system disorders | Non-systematic Assessment | Patient experienced increased resting tremor while on medication, but was unsure if medication was the cause. |
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| Dizziness and Light-Headedness | Nervous system disorders | Non-systematic Assessment | Patient experienced both dizziness and light-headedness while on medication, but was unsure if medication was the cause. |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |