Global Alzheimer's Platform Foundation
Global Alzheimer's Platform Foundation
A Pilot Project to Enhance Recruitment into Clinical Trials Supported by ADDF
The GAP Foundation is a patient-centered not-for-profit foundation devoted to speeding the development of new medicines for Alzheimer's disease (AD) by engaging patients in the clinical trial process and reducing unnecessary administrative burden in trial conduct. Recruitment into clinical trials is often slow and the rate limiting step in completing trials of potential new medicines for patients with AD. The difficulty in recruiting patients is even greater for studies of persons at risk for AD because they are not currently in clinical care and must be identified thru several screening procedures including cognitive tests, medical history and, possibly, brain imaging or lumbar puncture. At present phase 2 and 3 trials can take from a minimum of 2 to as long as 8 years to complete. The GAP foundation has developed several initiatives to increase the flow of potential study participants at clinical trial sites testing new medicines for AD. These include electronic patient engagement thru registries linking potential participants with clinical trial sites, establishing collaborations between health insurers, accountable care organizations, government agencies and clinical trial sites to increase the flow of potential participants, call centers managed centrally but branded locally to enhance the efficiency of participant screening and the development of efficient screening methods to diminish the amount of unnecessary testing and time on the part of both participants and clinical site staff. A network of GAP clinical sites (GAP-Net) will use these recruitment resources and streamlined administrative processes. We are proposing to use GAP resources and initiatives to determine whether they can speed the completion of at least one ADDF sponsored clinical trial in year 1. If successful the program could be continued to include other protocols jointly agreed to by ADDF and GAP.