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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS052318 | U.S. NIH Grant/Contract | View source | |
| OCR17539 | Other Identifier | Universiy of Florida |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this research study is to investigate how the brain and motor behavior changes Parkinson's Disease (PD) over time in response to Exenatide. In previous clinical trials, PD patients have experienced symptomatic improvement on Exenatide and literature suggests it may help slow the progression of Parkinson's. Both will be evaluated in this study.
Participants will receive baseline testing to confirm a diagnosis of Parkinson's Disease and to determine eligibility in the research study. All of the participants in this study will receive the study drug (Exenatide). The study drug will be provided at the end of the first visit, and participants will be administered the drug once per week for the duration of the study (1 year).
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 |
|---|---|---|---|
| Exenatide | Experimental | This group will receive a weekly Exenatide 2mg injection for one year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | Exenatide will be administered through a subcutaneous injection once per week for the duration of the study (1 year). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in free-water accumulation in the substantia nigra | 12-month study in PD to watch the effect of Exenatide on the progressive increase of free-water accumulation in the substantia nigra. | Baseline and one-year |
| Change in blood oxygen level-dependent(BOLD) signal in the posterior putamen. | 12-month study in PD to watch the effect of Exenatide on BOLD signal in the posterior putamen. | Baseline and one-year |
| Change in blood oxygen level-dependent(BOLD) signal in M1. | 12-month study in PD to watch the effect of Exenatide on BOLD signal in M1. | Baseline and one-year |
| Change in blood oxygen level-dependent(BOLD) signal in the supplementary motor area(SMA). | 12-month study in PD to watch the effect of Exenatide on BOLD signal in the SMA. | Baseline and one-year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Vaillancourt, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for Rehabilitation Neuroscience | Gainesville | Florida | 32611 | United States |
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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 |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |