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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
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Andrew B. West, University of Alabama at Birmingham

Tracking Information
First Submitted Date April 19, 2013
First Posted Date May 22, 2013
Last Update Posted Date May 11, 2018
Study Start Date January 2013
Actual Primary Completion Date June 21, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 20, 2013)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease
Official Title LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease
Brief Summary This proposal seeks to 1) determine whether there are biomarkers associated with Parkinson's disease (PD) susceptibility and/or progression in exosome-proteomes derived from PD patients versus controls, and 2) to 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood samples and urine
Sampling Method Non-Probability Sample
Study Population Neurology clinic
Condition Parkinson's Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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.
  • Healthy Control
    Healthy controls between ages of 21-99 years and a lack of PD in first-degree blood relatives
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 11, 2016)
601
Original Estimated Enrollment
 (submitted: May 20, 2013)
700
Actual Study Completion Date June 21, 2016
Actual Primary Completion Date June 21, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01860118
Other Study ID Numbers X121207003
1U18NS082132 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andrew B. West, University of Alabama at Birmingham
Study Sponsor University of Alabama at Birmingham
Collaborators National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Andrew West, PhD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date May 2018