NCT01246336

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

November 21, 2010

Last Update Submit

October 30, 2017

Conditions

Parkinson's DiseaseParkinsonism

Keywords

Parkinson's disease, ParkinsonismBiomarkersExhaled breathNanothechnology

Outcome Measures

Primary Outcomes (1)

  • Nanosensory detection

    analyze combinations of nanomaterial-based sensors (organically functionalized carbon nanotubes and gold nanoparticles)

    immediate

Study Arms (2)

Patients with parkinsonism

Patients suffering from Parkinson's disease or parkinsonism

Other: collection of exhaled breath

Healthy controls

Patients not suffering from Parkinson's disease or any other neurological disorder

Other: collection of exhaled breath

Interventions

collection of exhaled breathOTHER

no intervention

Healthy controlsPatients with parkinsonism

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with Idiopathic Parkinson's disease and Parkinsonism will be included.

You may qualify if:

  • Patients with Parkinsonism

You may not qualify if:

  • Severe dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Ilana Schlesinger, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ilana Schleainger, Rambam Health Care Campus

Study Record Dates

First Submitted

November 21, 2010

First Posted

November 23, 2010

Study Start

August 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

October 31, 2017

Record last verified: 2017-10