Parkinson's DiseaseNCT01246336
Exploratory Study Using Nanotechnology to Detect Biomarkers of Parkinson's Disease From Exhaled Breath
An observational study of Parkinson's Disease and Parkinsonism, run by Rambam Health Care Campus.
Trial summary
Parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis and differential diagnosis are not yet available. Exhaled breath testing may yield a "breath-print" that can be used to distinguish healthy and diseased states. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Parkinsonism
- What is being tested?
- collection of exhaled breath
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Jan 2012
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with Idiopathic Parkinson's disease and Parkinsonism will be included.
Who may be able to join
- Patients with Parkinsonism
Who cannot join
- Severe dementia
About this study
Official title: Exploratory Study to Detect Volatile Biomarkers of Idiopathic Parkinson's Disease and Parkinsonism From Exhaled Breath Using a Nanomedical Artificial Olfactory System.
Parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis and differential diagnosis are not yet available. Exhaled breath testing may yield a "breath-print" that can be used to distinguish healthy and diseased states.
- Conditions
- Parkinson's Disease, Parkinsonism
- Being tested
- collection of exhaled breath
- Keywords
- Parkinson's disease, Parkinsonism, Biomarkers, Exhaled breath, Nanothechnology
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of exhaled breathOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with parkinsonism | Patients suffering from Parkinson's disease or parkinsonism Receives: Other: collection of exhaled breath | |
| Healthy controls | Patients not suffering from Parkinson's disease or any other neurological disorder Receives: Other: collection of exhaled breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nanosensory detection
analyze combinations of nanomaterial-based sensors (organically functionalized carbon nanotubes and gold nanoparticles)
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startAug 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's 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
- Other
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Principal investigator, Ilana Schlesinger, Rambam Health Care Campus
- Investigators
- Ilana Schlesinger, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246336
- Sponsor's protocol ID
- RMB09-0196
- Status last verified
- Oct 2017
- First submitted
- 21 Nov 2010
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gupta R, Kumar R, Kumar N, Singh P. Reimagining Brain Drug Delivery: Mechanistic and Translational Advances in Carbon Nanotube Nanomedicine. J Appl Toxicol. 2026 Jul;46(7):2250-2274. doi: 10.1002/jat.70154. Epub 2026 Mar 24.
PubMed 41873211
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Detect Volatile Biomarkers of Idiopathic Parkinson's Disease and Parkinsonism From Exhaled Breath Using a Nanomedical Artificial Olfactory System.
- ClinicalTrials.gov ID
- NCT01246336
- Acronym / sponsor ID
- RMB09-0196
- Conditions
- Parkinson's Disease, Parkinsonism
- Keywords
- Parkinson's disease, Parkinsonism, Biomarkers, Exhaled breath, Nanothechnology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Aug 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Nov 2010 (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.
Parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis and differential diagnosis are not yet available. Exhaled breath testing may yield a "breath-print" that can be used to distinguish healthy and diseased states.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with parkinsonism | – | Other: collection of exhaled breathPatients suffering from Parkinson's disease or parkinsonism |
| Healthy controls | – | Other: collection of exhaled breathPatients not suffering from Parkinson's disease or any other neurological disorder |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Idiopathic Parkinson's disease and Parkinsonism will be included.
Key inclusion criteria (1 listed)
- Patients with Parkinsonism
Key exclusion criteria (1 listed)
- Severe dementia
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 |
|---|---|---|
| collection of exhaled breathno intervention | Other | Healthy controls, Patients with parkinsonism |
Primary outcome
Nanosensory detection
Time frame: immediate
analyze combinations of nanomaterial-based sensors (organically functionalized carbon nanotubes and gold nanoparticles)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Derived from this study: PubMed 41873211Gupta R, Kumar R, Kumar N, Singh P. Reimagining Brain Drug Delivery: Mechanistic and Translational Advances in Carbon Nanotube Nanomedicine. J Appl Toxicol. 2026 Jul;46(7):2250-2274. doi: 10.1002/jat.70154. Epub 2026 Mar 24.
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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.
Ilana Schlesinger, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Parkinsonism, run by Rambam Health Care Campus.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nanosensory detection (time frame: immediate). 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 NCT01246336, which also lists 1 linked publication.
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 Oct 2017.