Brief Title
Diagnostic and Prognostic Biomarkers in Parkinson Disease
Official Title
Blood Alpha-Synuclein, Gene Expression, and Smell Testing as Diagnostic and Prognostic Biomarkers in Parkinson's Disease
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.
Detailed Description
PROBE will test three biomarkers in PD subjects and controls to determine their feasibility
and potential utility as markers of risk and prognosis for PD. This is a case control study,
in which PD subjects will be compared to neurologically healthy controls and disease controls
(MSA and PSP). The blood biomarker samples will be drawn once to evaluate blood
alpha-synuclein levels as well as collection of lymphocyte mass for array analysis. Olfaction
will be measured using the UPSIT for all subjects. The UPSIT will be conducted as part of
PostCEPT for PD subjects and will only be repeated in this study for PD subjects in not done
within 6 months. Control subjects may also choose to submit a blood specimen for processing
and storage at the Coriell Institute for Medical Research, a research resource supported by
the NINDS Human Genetics Resource Center.
Follow-up of the PD population over a 3-year period will allow us to evaluate the prognosis
for important motor aspects of PD that will occur frequently in this cohort. These
complications of PD include motor complications, postural instability, and non-motor
impairment such as cognitive decline.
Healthy and disease control subjects may give permission at the Baseline visit to be
contacted and followed in the previously established PSG FOUND study using mail and telephone
contact to assess clinical status. Participation in the FOUND study provides another
mechanism to maintain contact with subjects and collect supplemental data beyond that
collected at the PROBE Baseline visit.
Study Type
Observational
Primary Outcome
α-synuclein, transcriptomic profiles and olfactory function
Secondary Outcome
Unified Parkinson Disease Rating Scale (UPDRS)
Condition
Parkinson Disease
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
200
Start Date
August 2007
Primary Completion Date
July 2008
Eligibility Criteria
Parkinson Disease Inclusion Criteria:
- Subject is participating in PostCEPT and meets UK brain bank criteria for PD
- Willing and able to provide informed consent
Healthy Control Inclusion Criteria:
- 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
Parkinsonism/Disease Control Inclusion Criteria (MSA and PSP)
- A diagnosis of Probable MSA based on Consensus Criteria OR Probable PSP based on
NINDS-PSP Criteria
- Willing and able to provide informed consent
Exclusion Criteria for All Groups:
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Bernard Ravina, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00653783
Organization ID
U01NS050095-02_PROBE
Secondary IDs
DOD Grant # W81XWH-07-1-0007
Study Sponsor
The Parkinson Study Group
Collaborators
United States Department of Defense
Study Sponsor
Bernard Ravina, MD, Principal Investigator, University of Rochester
Verification Date
December 2008