NCT00315250|CompletedPhase 2
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Sponsor study identifier
interventional
225
1 country
1
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
June 2010
Actual (reported)We propose to build on preliminary data evaluating non-dopaminergic/non-motor clinical biomarkers to more fully assess these markers at the threshold of Parkinson disease (PD). Development of reliable biomarkers for both dopaminergic and non-dopaminergic manifestations of Parkinson disease (PD) and related disorders may dramatically accelerate research on PD etiology, pathophysiology, and therapeutics. Biomarkers are broadly defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Specific biomarkers may be useful at the onset of neurodegeneration, the onset of disease, and/or to mark disease progression.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
April 14, 2006
Actual (reported)April 18, 2006
Actual (reported)January 2010
Actual (reported)June 2010
Actual (reported)Assess the sensitivity and specificity of olfaction, upper limb kinematic behavior, cognition, voice, metabolomic, proteomic and gene expression profiling in categorizing Parkinson Syndrome (PS) vs non-PS
Assess the sensitivity and specificity of olfaction, upper limb kinematic behavior, cognition, voice, metabolomic, proteomic and gene expression profiling in categorizing Parkinson Syndrome (PS) vs non-PS defined by \>30% age expected loss of \[123I\]B-CIT SPECT uptake.
2 years
Assess sensitivity and specificity of olfaction, upper limb kinematic behavior, cognition, voice, metabolomic, proteomic and gene expression profiling in categorizing PS vs non-PS
2 years
Correlate progression of biomarker outcomes for olfaction, upper limb kinematic behavior, cognition, voice, metabolomic and gene expression profiling with progression of PS defined by % change from baseline in putamen [123I]ß-CIT SPECT uptake.
2 years
To assess B-CIT and SPECT imaging
Single Photon Emission Computed Tomography SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections), from multiple angles. A computer is then used to apply a tomographic reconstruction algorithm to the multiple projections, yielding a 3-D dataset. This dataset may then be manipulated to show thin slices along any chosen axis of the body, similar to those obtained from other tomographic techniques, such as MRI, CT, and PET. The resulting SPECT images reflect body/organ function as opposed to specific anatomy of other imaging modalities such as CT or MRI.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
Danna Jennings, MD
Institute for Neurodegenerative Disorders
225 participants (actual enrollment reported by the registry).
First Submitted
April 14, 2006
First Posted
April 18, 2006
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Assessing Imaging as a Tool in Monitoring and Predicting the Progression of Parkinson Disease
Contact the study team to confirm eligibility.
Primary Completion
January 2010
Actual (reported)Study Completion
June 2010
Actual (reported)Last Updated
May 9, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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