Systemic Synuclein Sampling Study (S4)

Completed

• Conditions: Parkinson's Disease
• Interventions: Procedure: Biofluid samplings; Procedure: Tissue samplings; Drug: DaTSCAN™

• Registration Number: NCT02572713
• Lead Sponsor: Michael J. Fox Foundation for Parkinson's Research

Brief Summary

The purpose of this study is to measure alpha-synuclein in peripheral body tissues and fluids in Parkinson's disease (PD). This may help in developing better treatments for PD patients in the future.

Detailed Description

This is a multi-center, cross-sectional, observational study to evaluate α-syn pathology in multiple tissues and biofluids in individual subjects with PD and HC at a single time point.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-09
• Status Verified: 2017-08
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early PD	Tissue samplings	20 early PD not requiring dopamine replacement therapy have been enrolled.
Healthy Controls	Biofluid samplings	21 healthy controls have been enrolled.
Advanced PD	Tissue samplings	21 advanced PD with motor fluctuations have been enrolled.
Advanced PD	DaTSCAN™	21 advanced PD with motor fluctuations have been enrolled.
Healthy Controls	DaTSCAN™	21 healthy controls have been enrolled.
Early PD	Biofluid samplings	20 early PD not requiring dopamine replacement therapy have been enrolled.
Moderate PD	Tissue samplings	20 moderate PD on dopamine replacement therapy without motor fluctuations have been enrolled.
Early PD	DaTSCAN™	20 early PD not requiring dopamine replacement therapy have been enrolled.
Moderate PD	DaTSCAN™	20 moderate PD on dopamine replacement therapy without motor fluctuations have been enrolled.
Moderate PD	Biofluid samplings	20 moderate PD on dopamine replacement therapy without motor fluctuations have been enrolled.
Advanced PD	Biofluid samplings	21 advanced PD with motor fluctuations have been enrolled.
Healthy Controls	Tissue samplings	21 healthy controls have been enrolled.

Primary Outcome Measures

Name	Time	Method
α-syn deposits in submandibular gland	24 months	α-syn burden in the submandibular tissue will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.
α-syn levels in blood	24 months	Blood will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
α-syn levels in saliva	24 months	Saliva will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
α-syn deposits in colon	24 months	α-syn burden in the colon tissue will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.
α-syn levels in CSF	24 months	CSF will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
α-syn deposits in skin	24 months	α-syn burden in skin biopsies will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.

Trial Locations

Locations (6)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

Institute for Neurodegenerative Disorders; 🇺🇸 New Haven, Connecticut, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Toronto Western Hospital Movement Disorders Centre; 🇨🇦 Toronto, Ontario, Canada