Progress

Since February 2008, when CAMD launched initial activity in three major areas — data sharing, disease modeling, and biomarkers — it has already reached significant milestones.

Alzheimer’s disease

  • Collaborated with the Clinical Data Interchange Standards Consortium (CDISC) to develop the first Alzheimer disease data standards for use in clinical trials and regulatory review.
  • Established a unified clinical database for Alzheimer’s disease containing anonymized, patient-level data of 6,500 patients from the control arms of 24 clinical studies. The database is available to qualified researchers around the world.
  • Developed a transformational quantitative clinical trial simulation tool for mild and moderate Alzheimer’s disease. This represents the first quantitative drug development platform to be endorsed by regulatory agencies.
  • Received the first imaging biomarker qualification for the use of volumetric magnetic resonance imaging (vMRI) to select patients with early stages of cognitive impairment for Alzheimer’s disease clinical trials from the European Medicines Agency (EMA).