Parkinson DiseaseSPIN-PDNCT01005030
Spectroscopy in Parkinson Disease
An observational study of Parkinson Disease, run by Molecular Biometrics, Inc. at 1 site in United States.
Trial summary
The primary objective of the study is to determine the utility of blood plasma infrared spectroscopy (biospectroscopy) in distinguishing subjects with idiopathic Parkinson's disease from healthy controls. Read more about this study
- Who is it for?
- Ages 46 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Blood draw
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2014
- 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 46 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's subjects: from pool of subjects currently enrolled in PostCEPT study Control subjects: general population
Who may be able to join
- PD Subjects:
- PostCEPT subjects with a diagnosis of PD based on UK Brain Bank criteria.
- Willing and able to provide informed consent.
- Healthy Controls:
- No current diagnosis or known history of a neurological disease/disorder.
- Non-blood relative of a patient or subject at the site who has diagnosis of PD (may include healthy controls from the PROBE study).
Show all 10Show fewer
- No first degree relatives with diagnosis of PD
- MoCA score > 26.
- Age > 45.
- Willing and able to provide informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Blood Biospectroscopy as a Novel Diagnostic Test for Idiopathic Parkinson Disease
The primary objective of the study is to determine the utility of blood plasma infrared spectroscopy (biospectroscopy) in distinguishing subjects with idiopathic Parkinson's disease from healthy controls.
Read the detailed description
Oxidative stress has been implicated as a factor in the pathogenesis of Parkinson's disease (PD). The overall goal of this proposal is to use a novel metabolomics platform, based on near infrared biospectroscopy, to detect oxidatively modified blood plasma constituents. These spectral findings can be used to model the degree of oxidative stress with a modeled "stress index" that may distinguish PD cases from healthy elderly controls.
- Conditions
- Parkinson Disease
- Being tested
- Blood draw
- Keywords
- Parkinson Disease, blood, plasma, metabolomics, spectroscopy, oxidative stress.
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
Blood draw, two tubes, used for isolation of cell-free blood plasma
| Study group | Role | What they receive |
|---|---|---|
| PostCEPT Subjects | Subjects with current Parkinson Disease Diagnosis currently enrolled in PostCEPT study Receives: Other: Blood draw | |
| Control Subjects | Non-blood relatives of PostCEPT Subjects matched for age and other demographics Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study is the correct classification of cases of PD and controls. This will be quantified as sensitivity and specificity.
Measured: Baseline and annually for two years
Secondary outcomes (2)
Determine impact of disease stage, age, gender, medications, cognitive scores, other laboratory measures (e.g. alpha-synuclein) and other clinical/demographic variables on plasma biospectra.
Measured: Baseline and annually for two years
Correlate plasma biospectra with dopamine transporter neuroimaging data.
Measured: Baseline and annually for two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molecular Biometrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Investigators
- Bernard Ravina, MD, Principal investigator, University of RochesterAnthony E Lang, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005030
- Sponsor's protocol ID
- MB_PD001
- Acronym
- SPIN-PD
- Status last verified
- Nov 2009
- First submitted
- 29 Oct 2009
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Burns DH, Rosendahl S, Bandilla D, Maes OC, Chertkow HM, Schipper HM. Near-infrared spectroscopy of blood plasma for diagnosis of sporadic Alzheimer's disease. J Alzheimers Dis. 2009;17(2):391-7. doi: 10.3233/JAD-2009-1053.
PubMed 19363272Schipper HM, Kwok CS, Rosendahl SM, Bandilla D, Maes O, Melmed C, Rabinovitch D, Burns DH. Spectroscopy of human plasma for diagnosis of idiopathic Parkinson's disease. Biomark Med. 2008 Jun;2(3):229-38. doi: 10.2217/17520363.2.3.229.
PubMed 20477412
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blood Biospectroscopy as a Novel Diagnostic Test for Idiopathic Parkinson Disease
- ClinicalTrials.gov ID
- NCT01005030
- Acronym / sponsor ID
- SPIN-PD / MB_PD001
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, blood, plasma, metabolomics, spectroscopy, oxidative stress.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Molecular Biometrics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Oct 2009
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 30 Oct 2009 (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 primary objective of the study is to determine the utility of blood plasma infrared spectroscopy (biospectroscopy) in distinguishing subjects with idiopathic Parkinson's disease from healthy controls.
Detailed description
Oxidative stress has been implicated as a factor in the pathogenesis of Parkinson's disease (PD). The overall goal of this proposal is to use a novel metabolomics platform, based on near infrared biospectroscopy, to detect oxidatively modified blood plasma constituents. These spectral findings can be used to model the degree of oxidative stress with a modeled "stress index" that may distinguish PD cases from healthy elderly controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PostCEPT Subjects | – | Other: Blood drawSubjects with current Parkinson Disease Diagnosis currently enrolled in PostCEPT study |
| Control Subjects | – | Other: Blood drawNon-blood relatives of PostCEPT Subjects matched for age and other demographics |
Who may qualify
- Ages
- 46 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's subjects: from pool of subjects currently enrolled in PostCEPT study Control subjects: general population
Key inclusion criteria (10 listed)
- PostCEPT subjects with a diagnosis of PD based on UK Brain Bank criteria.
- Willing and able to provide informed consent.
- No current diagnosis or known history of a neurological disease/disorder.
- Non-blood relative of a patient or subject at the site who has diagnosis of PD (may include healthy controls from the PROBE study).
- No first degree relatives with diagnosis of PD
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawBlood draw, two tubes, used for isolation of cell-free blood plasma | Other | Control Subjects, PostCEPT Subjects |
Primary outcome
The primary outcome of the study is the correct classification of cases of PD and controls. This will be quantified as sensitivity and specificity.
Time frame: Baseline and annually for two years
2 secondary outcomes
Determine impact of disease stage, age, gender, medications, cognitive scores, other laboratory measures (e.g. alpha-synuclein) and other clinical/demographic variables on plasma biospectra.
Time frame: Baseline and annually for two years
Correlate plasma biospectra with dopamine transporter neuroimaging data.
Time frame: Baseline and annually for two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2009.
- Background: PubMed 19363272Burns DH, Rosendahl S, Bandilla D, Maes OC, Chertkow HM, Schipper HM. Near-infrared spectroscopy of blood plasma for diagnosis of sporadic Alzheimer's disease. J Alzheimers Dis. 2009;17(2):391-7. doi: 10.3233/JAD-2009-1053.
- Background: PubMed 20477412Schipper HM, Kwok CS, Rosendahl SM, Bandilla D, Maes O, Melmed C, Rabinovitch D, Burns DH. Spectroscopy of human plasma for diagnosis of idiopathic Parkinson's disease. Biomark Med. 2008 Jun;2(3):229-38. doi: 10.2217/17520363.2.3.229.
- The Parkinson Study Group (PSG) is a non-profit, cooperative group of Parkinson's disease experts from medical centers in the United States and Canada who are dedicated to improving treatment for persons affected by Parkinson's disease.Link provided by the sponsor.
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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
Anthony E Lang, MD principal investigator
University of Toronto
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, run by Molecular Biometrics, Inc. 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 10 inclusion and 0 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 10 Nov 2009. 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?
The primary outcome of the study is the correct classification of cases of PD and controls. This will be quantified as sensitivity and specificity. (time frame: Baseline and annually for two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01005030, which also lists 2 linked publications.
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 10 Nov 2009.