Diagnostic and Prognostic Biomarkers in Parkinson Disease

NCT00653783 | Unknown

• 4 other identifiers: U01NS050095-02_PROBEDOD Grant # W81XWH-07-1-0007NINDS Grant 5 U01 NS050095-02U01NS050095-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of PROBE is to evaluate the feasibility and potential utility of three markers (alpha-synuclein, transcriptomic profiles and olfactory function) to determine the risk or prognosis of PD.

Conditions

Parkinson Disease; Multiple System Atrophy; Progressive Supranuclear Palsy

Keywords

Parkinson disease; Multiple System Atrophy; MSA; Progressive Supranuclear Palsy; PSP; observational; biomarker

Outcome Measures

Primary Outcomes (1)

• α-synuclein, transcriptomic profiles and olfactory function

  Three years

Secondary Outcomes (2)

• Unified Parkinson Disease Rating Scale (UPDRS)

  Three Years

• University of Pennsylvania Smell Identification Test (UPSIT)

  Three Years

Eligibility Criteria

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

Study Population

primary care clinic, spouses, PD patients from another trial

You may qualify if:

• Subject is participating in PostCEPT and meets UK brain bank criteria for PD
• Willing and able to provide informed consent
• Spouse or non blood relative of the PD subject
• No known current diagnosis or history of a neurological disease
• MMSE score \>27
• Age \>45
• Willing and able to provide informed consent
• A diagnosis of Probable MSA based on Consensus Criteria OR Probable PSP based on NINDS-PSP Criteria
• Willing and able to provide informed consent

You may not qualify if:

• Current use (within 7 days prior to Baseline Visit) of anticoagulants (e.g., warfarin or heparin)
• Known bleeding disorder (acquired or inherited)
• Known blood disorder (e.g. leukemia) or a history of anemia with a documented hematocrit \<30
• Known pregnancy
• History of nasal trauma, sinusitis, or other nasal pathology that would interfere with smell testing

Sponsors & Collaborators

• The Parkinson Study Group: lead
• United States Department of Defense: collaborator

Study Sites (1)

Parkinson Study Group

Rochester, New York, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, serum

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernard Ravina, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Last Updated: December 31, 2008

Record last verified: 2008-12

Locations

US (1)