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Qualification study in healthy volunteers prompts investigators to explore fluctuation of markers in Parkinson's disease subjects

As part of the planning phase of PPMI last fall, MJFF sponsored a qualification study to assess the test/re-test reliability of specific biomarker assays and to determine whether there was a diurnal fluctuation of the potential PD biomarkers alpha-synuclein and DJ-1 in healthy volunteers. CSF and serum/plasma were collected from 13 control subjects at 11 time points within a 26 hour time period. This exact same protocol was repeated on subjects 2 weeks later. The study determined that there was an increase in some markers over the course of the collection period, which suggests  that the time at which CSF samples are collected in clinical trials could may affect the standardization of the study.


Upon reviewing these findings, the study leaders decided to repeat the qualification study in Parkinson’s patients and older controls to determine whether the same changes in proteins over the course of a day occurs in a PD and older population. This new study is currently recruiting 12 PD patients and 6 age- and gender-matched controls who will be hospitalized for 4 days. Two days will require lumbar catheterization, which will be followed by a day of rest and monitoring. Results from this study are expected in Winter 2012.


To learn more about these qualification studies or to review the study protocols, click here.


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