LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

LRRK2 and Other Novel Exosome Proteins in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860118
• Other study ID #: X121207003
• Secondary ID: 1U18NS082132
• Status: Completed
• Start date: January 2013
• Est. completion date: June 21, 2016

Study information

• Verified date: May 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: June 21, 2016
• Est. primary completion date: June 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Sparks Center	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	LRRK2 expression and/or phosphorylation	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.	up to 3 years