Parkinson's Disease Clinical Trial
Official title:
Development of Imaging, Clinical and Biochemical Bio-Markers for Parkinson's Disease
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.
Status | Completed |
Enrollment | 225 |
Est. completion date | June 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 22 Years and older |
Eligibility |
Inclusion Criteria: - Older than 21 - Any parkinsonian symptoms - Referral by community neurologist - Parkinsonian symptoms for less than 2 years duration. - Willingness to follow the study plan. Exclusion Criteria: - Pregnancy - Significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal electrocardiogram (ECG - tracing of the electrical activity of the heart) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Institute for Neurodegenerative Disorders | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Institute for Neurodegenerative Disorders | Molecular NeuroImaging, United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Assess sensitivity and specificity of olfaction, upper limb kinematic behavior, cognition, voice, metabolomic, proteomic and gene expression profiling in categorizing PS vs non-PS | Assess sensitivity and specificity of olfaction, upper limb kinematic behavior, cognition, voice, metabolomic, proteomic and gene expression profiling in categorizing PS vs non-PSby clinical exam by a movement disorders expert (blinded to any imaging data) after 12 months of subject follow up. | 2 years | No |
Secondary | 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 | No |
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