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.
Two hundred patients who have undergone neurological evaluation by their general community
neurologist and have a questionable diagnosis of PD will be recruited to participate in this
study. Subjects will be referred by the neurologists to the Institute for Neurodegenerative
Disorders (IND) in New Haven, CT.
All subjects will be clinically evaluated at IND by a two movement disorders experts. At the
baseline visit all subjects will also undergo [123I]ß-CIT SPECT ANAM, voice acoustics,
olfactory, Spiral and biochemical testing. Each movement disorders expert will make an
initial clinical diagnosis at baseline and again within three months follow-up. At the three
month visit one movement disorder expert will be provided the DAT imaging data and will
review that data with the subjects and referral physician. The other movement disorders
physician will remain blind to the imaging and all other biomarker data. The blinded
movement disorders expert will provide a final clinical diagnosis at the 12 month follow-up
visit, which will represent the 'gold standard' diagnosis in this study. Statistical
analysis to determine the sensitivity and specificity of ANAM, voice acoustics, olfactory,
Spiral and biochemical testing compared to [123I]ß-CIT SPECT, and the gold standard clinical
diagnosis will be completed. All subjects with DAT deficit and 10% of those without DAT
deficit will be asked to return for repeat evaluation at 24 months.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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