LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT01860118 |
Recruitment Status :
Completed
First Posted : May 22, 2013
Last Update Posted : May 11, 2018
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Condition or disease |
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Parkinson's Disease |
Study Type : | Observational |
Actual Enrollment : | 601 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | June 21, 2016 |
Actual Study Completion Date : | June 21, 2016 |

Group/Cohort |
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Parkinson's Disease
1) the presence of bradykinesia and either rest tremor or rigidity; 2) asymmetric onset; 3) progressive motor symptoms 4) age at onset 21-99 years.
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Healthy Control
Healthy controls between ages of 21-99 years and a lack of PD in first-degree blood relatives
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- Biomarkers [ Time Frame: up to 3 years ]Biomarkers associated with Parkinson's disease (PD) susceptibility and/or progression in exosome-proteomes derived from PD patients versus controls.
- LRRK2 expression and/or phosphorylation [ Time Frame: up to 3 years ]Determine if LRRK2 expression and/or phosphorylation are significantly lowered in the exosomes of individuals treated with the potent LRRK2 kinase inhibitor sunitinib (a multi-kinase inhibitor compound), to establish an assay for on-target effects for future LRRK2 inhibitor clinical trials.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Parkinson's disease inclusion criteria:
Inclusion criteria will be based on UK Brain Bank criteria for the clinical diagnosis of PD. These require 1) the presence of bradykinesia and either rest tremor or rigidity; 2) asymmetric onset; 3) progressive motor symptoms 4) age at onset 21-99 years.
Control inclusion criteria: ages of between 21-99 years, a lack of PD in first-degree blood relatives, and a lack of positive responses on more than 3 items on the PD Screening Questionnaire.
Exclusion Criteria:
For all subjects:
include atypical features indicative of a Parkinson-Plus disorder (Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD)) including cerebellar signs, supranuclear gaze palsy, apraxia and other cortical signs, or prominent autonomic failure, neuroleptic treatment at time of onset of parkinsonism, active treatment with a neuroleptic at time of study entry, History of repeated strokes with stepwise progression of parkinsonism, history of repeated head injury, history of definite encephalitis, prominent gait imbalance early in the course (< 5 years), dementia, known severe anemia (hematocrit <30), history of kidney disease and/or current or past glomerular filtration rate (GFR) <60 possibly indicative of kidney disease, or a serious comorbidity that may interfere with participation in the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860118
United States, Alabama | |
University of Alabama at Birmingham Sparks Center | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Andrew West, PhD | University of Alabama at Birmingham |
Responsible Party: | Andrew B. West, Associate Professor, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT01860118 |
Other Study ID Numbers: |
X121207003 1U18NS082132 ( U.S. NIH Grant/Contract ) |
First Posted: | May 22, 2013 Key Record Dates |
Last Update Posted: | May 11, 2018 |
Last Verified: | May 2018 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |