NCT01291550

Brief 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 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).

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2011

Completed
Last Updated

February 8, 2011

Status Verified

September 1, 2010

First QC Date

February 7, 2011

Last Update Submit

February 7, 2011

Conditions

Keywords

Detecting volatile biomarkers using breath sample

Study Arms (3)

Nerodegenerative diseases

Patients with parkinsonism and patients with dementia

Controls

ADHD

Subjects diagnosed with ADHD

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Out patient clinic patients diagnosed with neurodegenerative conditions healthy control and subjects diagnosed with ADHD.

You may qualify if:

  • Patients diagnosed with neurodegenerative conditions
  • Healthy subjects
  • Subjects diagnosed with ADHD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cognitive Neurology, Rambam Medical Center

Haifa, 31096, Israel

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 8, 2011

Study Start

September 1, 2010

Last Updated

February 8, 2011

Record last verified: 2010-09

Locations