The Critical Path For Alzheimer’s Disease (CPAD) is a public-private partnership aimed at creating new tools and methods that can be applied to increase the efficiency of the development process of new treatments for Alzheimer’s disease (AD) and related neurodegenerative disorders with impaired cognition and function.
CPAD has a mission to develop new technologies and methods to accelerate the development and review of medical products for neurodegenerative diseases.
CPAD is focused on accelerating therapeutic treatment development for patients with chronic neurodegenerative disease, namely, Alzheimer’s disease (AD), the most prevalent and devastating dementia, by advancing drug development tools (DDTs) and when appropriate, medical device development tools (MDDTs) for evaluating drug efficacy, conducting clinical trials, and streamlining the process of regulatory review. The consortium focuses on sharing precompetitive patient-level data from the control arms of legacy clinical trials, developing new tools to be submitted to the regulatory agencies, and developing consensus data standards.
CPAD has the following areas of focus: (1) qualification of objective biomarkers, including both biochemical and observational digital biosensor measures of health, (2) development of common data standards, (3) creation of integrated databases for clinical trials data, and (4) development of quantitative model-based tools for therapeutics development.
Regulatory milestones for CPAD include a qualification opinion with EMA for the use of low baseline hippocampal volume for patient enrichment in pre-dementia trials, and, more recently, positive regulatory decisions from the FDA and EMA for the use of a clinical trial simulation tool to aid in trials for mild to moderate stages of AD.
Until December 2015, CPAD focused on projects that spanned AD and Parkinson’s disease. Starting in January 2016, a newly formed consortium, Critical Path for Parkinson’s (CPP) consortium, will assume responsibilities for the projects initiated by CPAD. CPP was enabled by a generous donation by the Parkinson’s UK Foundation and will be led by Dr. Diane Stephenson as Executive Director.