LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease

NCT01860118 | Completed

• 2 other identifiers: X1212070031U18NS082132
• Study Type: observational
• Target: 601
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Biomarkers

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

  up to 3 years

Secondary Outcomes (1)

• LRRK2 expression and/or phosphorylation

  up to 3 years

Study Arms (2)

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neurology clinic

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Alabama at Birmingham Sparks Center

Birmingham, Alabama, 35294, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples and urine

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Andrew West, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 22, 2013
• Study Start: January 1, 2013
• Primary Completion: June 21, 2016
• Study Completion: June 21, 2016
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)