Parkinson DiseasePROBENCT00653783
Diagnostic and Prognostic Biomarkers in Parkinson Disease
An observational study of Parkinson Disease and Multiple System Atrophy, run by The Parkinson Study Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Multiple System Atrophy, Progressive Supranuclear Palsy
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic, spouses, PD patients from another trial
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Alpha-Synuclein, Gene Expression, and Smell Testing as Diagnostic and Prognostic Biomarkers in Parkinson's Disease
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.
Read the 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.
- Keywords
- Parkinson disease, Multiple System Atrophy, MSA, Progressive Supranuclear Palsy, PSP, observational, biomarker
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive
What is being measured
The primary outcome is the main question the study is designed to answer.
α-synuclein, transcriptomic profiles and olfactory function
Measured: Three years
Secondary outcomes (2)
Unified Parkinson Disease Rating Scale (UPDRS)
Measured: Three Years
University of Pennsylvania Smell Identification Test (UPSIT)
Measured: Three Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startAug 2007
- Primary completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Parkinson Study Group
- Sponsor type
- Research network
- Collaborators
- United States Department of Defense
- Investigators
- Bernard Ravina, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653783
- Sponsor's protocol ID
- U01NS050095-02_PROBE
- Other IDs
- DOD Grant # W81XWH-07-1-0007, NINDS Grant 5 U01 NS050095-02, U01NS050095-02
- Acronym
- PROBE
- Status last verified
- Dec 2008
- First submitted
- 2 Apr 2008
- Last updated
- 31 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Alpha-Synuclein, Gene Expression, and Smell Testing as Diagnostic and Prognostic Biomarkers in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00653783
- Acronym / sponsor ID
- PROBE / U01NS050095-02_PROBE
- Keywords
- Parkinson disease, Multiple System Atrophy, MSA, Progressive Supranuclear Palsy, PSP, observational, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Parkinson Study GroupResearch network
- Collaborators
- United States Department of Defense
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (estimated)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic, spouses, PD patients from another trial
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
α-synuclein, transcriptomic profiles and olfactory function
Time frame: Three years
2 secondary outcomes
Unified Parkinson Disease Rating Scale (UPDRS)
Time frame: Three Years
University of Pennsylvania Smell Identification Test (UPSIT)
Time frame: Three Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Ravina, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Multiple System Atrophy, run by The Parkinson Study Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
α-synuclein, transcriptomic profiles and olfactory function (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2008.