Status:
COMPLETED
LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson's Disease
Eligibility:
All Genders
21+ years
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 control...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2016
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT01860118
Start Date
January 1 2013
End Date
June 21 2016
Last Update
May 11 2018
Active Locations (1)
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1
University of Alabama at Birmingham Sparks Center
Birmingham, Alabama, United States, 35294