Placebo Data Analysis in Alzheimer’s Diseases/Mild Cognitive Impairment
At a Glance
- Status: Completed Consortium
- Year Launched: 2009
- Initiating Organization: Foundation for the National Institutes of Health
- Initiator Type: Nonprofit foundation
- Disease focus:
- Location: North America
The Placebo Data Analysis in Alzheimer’s Diseases/Mild Cognitive Impairment (PDA) consortium aims to combine placebo data from large clinical trials provided by multiple pharmaceutical companies with the original goal of creating datasets of 3,000 to 5,000 subjects for Alzheimer's disease (AD) and mild cognitive impairment (MCI) groups. The long-term goal is to develop better measures of disease progression -- outcome measures that have both low variability and are sensitive to change -- for use in future clinical trials.
In 2010, the Biomarkers Consortium launched the "Placebo Data Analysis in Alzheimer's Disease and Mild Cognitive Impairment Clinical Trials" consortium to pursue two specific goals: 1) collect the placebo arm data from the key multicenter clinical trials conducted by pharmaceutical and biotechnology companies and academia over the past 20 years of Alzheimer’s Diseases/Mild Cognitive Impairment research, and 2) to conduct statistical analysis of the pooled data to address a number of open questions in AD trial design, including characterizing progression over multiple domains, instrument refinement, prognostic factor detection, and providing insight into dropout patterns.
Sponsors & Partners
The Foundation for the National Institutes of Health will manage and administer this project. Principal Investigators are Marilyn Albert, Ron Petersen, Paul Aisen, Ronald Thomas. Project Chair is Maria Carrillo.
Foundation for the National Institutes of Health