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N/A
21 Years
N/A
Open (Enrolling)
Both
Parkinson's Disease

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Trial Information


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.

Sunitinib cohort criteria:

Neurologically normal patients, without history of PD, currently undergoing sunitinib
treatment for cancer. Urine will be collected 4-hours (peak serum drug levels in most
people) after their usual AM dosage of drug (cancers include pheochromocytoma, carcinoid,
or renal cancer with still normal kidney function (GFR >60), all seen at the UAB
Comprehensive Cancer center). Current age from 21 to 99 will be collected.

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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Biomarkers

Outcome Description:

Biomarkers associated with Parkinson's disease (PD) susceptibility and/or progression in exosome-proteomes derived from PD patients versus controls.

Outcome Time Frame:

up to 3 years

Safety Issue:

No

Principal Investigator

Andrew West, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Institutional Review Board

Study ID:

1U18NS082132

NCT ID:

NCT01860118

Start Date:

January 2013

Completion Date:

January 2017

Related Keywords:

  • Parkinson's Disease
  • Parkinson Disease

Name

Location

University of Alabama at Birmingham Sparks CenterBirmingham, Alabama  35294