Neurodegenerative DiseasesNCT01291550
Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples
An observational study of Neurodegenerative Diseases, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify neurodegenerative conditions and ADHD based on… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to not given
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Out patient clinic patients diagnosed with neurodegenerative conditions healthy control and subjects diagnosed with ADHD.
Who may be able to join
- Patients diagnosed with neurodegenerative conditions
- Healthy subjects
- Subjects diagnosed with ADHD
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Cognitive Neurology, Rambam Medical Center
Haifa, 31096
Judith Aharon-Peretz, M.D, 97248543190, memory@rambam.health.gov.il
Michal Levavi, MA.RN
About this study
The diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify neurodegenerative conditions and ADHD based on breath testing.
Alveolar breath will be collected from healthy volunteers, patients with extrapyramidal conditions, patients diagnosed with dementia and from ADHD subjects. The discriminative power of a tailor-made Nanoscale Artificial Nose (™NA-NOSE) containing an array of six nanomaterial-based sensors will be tested. Discriminant factor analysis will be applied to the NA-NOSE signals in order to detect statistically significant differences between the sub-populations, and classification success will be estimated using leave-one-out cross-validation. The identification of NA-NOSE patterns will be supported by analyzing the chemical composition of the breath using gas-chromatography in conjunction with mass-spectrometry (GC-MS).
- Conditions
- Neurodegenerative Diseases
- Keywords
- Detecting volatile biomarkers using breath sample
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nerodegenerative diseases | Patients with parkinsonism and patients with dementia | |
| Controls | Not described | |
| ADHD | Subjects diagnosed with ADHD |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startSep 2010
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 Neurodegenerative DiseasesStudies 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
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291550
- Sponsor's protocol ID
- 0196-09
- Status last verified
- Sep 2010
- First submitted
- 7 Feb 2011
- Last updated
- 8 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Tisch U, Schlesinger I, Ionescu R, Nassar M, Axelrod N, Robertman D, Tessler Y, Azar F, Marmur A, Aharon-Peretz J, Haick H. Detection of Alzheimer's and Parkinson's disease from exhaled breath using nanomaterial-based sensors. Nanomedicine (Lond). 2013 Jan;8(1):43-56. doi: 10.2217/nnm.12.105. Epub 2012 Oct 15.
PubMed 23067372
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples
- ClinicalTrials.gov ID
- NCT01291550
- Acronym / sponsor ID
- 0196-09
- Conditions
- Neurodegenerative Diseases
- Keywords
- Detecting volatile biomarkers using breath sample
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Sep 2010
- First posted
- 8 Feb 2011 (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 diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify neurodegenerative conditions and ADHD based on breath testing.
Alveolar breath will be collected from healthy volunteers, patients with extrapyramidal conditions, patients diagnosed with dementia and from ADHD subjects. The discriminative power of a tailor-made Nanoscale Artificial Nose (™NA-NOSE) containing an array of six nanomaterial-based sensors will be tested. Discriminant factor analysis will be applied to the NA-NOSE signals in order to detect statistically significant differences between the sub-populations, and classification success will be estimated using leave-one-out cross-validation. The identification of NA-NOSE patterns will be supported by analyzing the chemical composition of the breath using gas-chromatography in conjunction with mass-spectrometry (GC-MS).
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nerodegenerative diseases | – | –Patients with parkinsonism and patients with dementia |
| Controls | – | – |
| ADHD | – | –Subjects diagnosed with ADHD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Out patient clinic patients diagnosed with neurodegenerative conditions healthy control and subjects diagnosed with ADHD.
Key inclusion criteria (3 listed)
- Patients diagnosed with neurodegenerative conditions
- Healthy subjects
- Subjects diagnosed with ADHD
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.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2011.
- Derived from this study: PubMed 23067372Tisch U, Schlesinger I, Ionescu R, Nassar M, Axelrod N, Robertman D, Tessler Y, Azar F, Marmur A, Aharon-Peretz J, Haick H. Detection of Alzheimer's and Parkinson's disease from exhaled breath using nanomaterial-based sensors. Nanomedicine (Lond). 2013 Jan;8(1):43-56. doi: 10.2217/nnm.12.105. Epub 2012 Oct 15.
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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.
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 Neurodegenerative Diseases, run by Rambam Health Care Campus at 1 site in Israel.
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 3 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 8 Feb 2011. 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291550, 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 8 Feb 2011.