fluid (CSF) and the standardization of imaging (Box 1-2). Industry members have collaborated so well, in the opinion of Potter and other workshop attendees, that they set a model for industry contributions to future Biomarkers Consortium projects.

While many advances are coming from the analysis of the image data, Potter expressed that collection of CSF may turn out to be more important than imaging biomarkers. This contribution was made possible through the advisory committee’s success in working with its public partner to modify the study design to collect CSF at much higher rates than initially called for in the protocol and by encouraging more patients, via an educational video, to willingly undergo lumbar puncture. The protocol originally called for 20 percent of each group to undergo lumbar puncture; however, through the aforementioned strategies, investigators have been successful in collecting CSF from close to 60 percent of participants. With this success also comes the challenge of analysis of the CSF. ADNI was not originally designed to perform detailed analysis on this quantity of CSF; therefore, according to Potter, new partnerships are necessary to take advantage of this opportunity.

BOX 1-2

Active Role of Industry’s Participation in Study Design

  • Raised the percentage of patients for CSF collection from 20 percent to close to 60 percent

  • Standardized collection, handling, and storage of CSF through development of a best practices protocol, which includes assays for proteins implicated in Alzheimer’s disease

  • Arranged for and cofunded an educational video to encourage contribution of CSF

  • Developed best practices for a standardized approach to brain imaging

  • Developed precompetitive algorithms for diagnosis

  • Organized a training workshop for statisticians and database managers

SOURCE: Potter, 2007.



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