Biomarkers Consortium - Placebo Data Analysis Project in Alzheimer’s Disease/Mild Cognitive Impairment Clinical Trials

The Biomarkers Consortium’s Placebo Data Analysis Project in Alzheimer’s Disease/Mild Cognitive Impairment Clinical Trials combined placebo data from large clinical trials provided by multiple pharmaceutical companies to create datasets of 3,000 to 5,000 subjects for Alzheimer’s disease (AD) and mild cognitive impairment (MCI) groups. The goal of the project was to develop better measures of disease progression in terms of outcome measures that have both low variability and are sensitive to change, for use in future clinical trials. To date, 40 datasets have been acquired by the Project Team and have been sent to the Alzheimer’s Disease Collaborative Study, for a total of over 9,000 placebo subjects.

Goals

  • Combine placebo data from large industry clinical trials and analyze them to provide better outcome measures (outcome measures that have both low variability and are sensitive to change) of cognition and disease progression for use in future AD/MCI clinical trials.

Results & Accomplishments

Primary analyses are complete. Trajectories were generally similar across trials and nearly linear. Greater cognitive impairment at baseline, younger age and greater education were associated with increased rate of cognitive decline. Effect sizes for the ADAScog were generated as a function of population characteristics.

Scientific Publications

Longitudinal decline in mild-to-moderate Alzheimer's disease: Analyses of placebo data from clinical trials. Thomas RG1, Albert M2, Petersen RC3, Aisen PS4. Alzheimers Dement. 2016 May;12(5):598-603.

Randomized controlled trials in mild cognitive impairment: Sources of variability. Peterson RC1, Thomas RG2, Aisen PS2, Mohs RC2, Carrillo MC2, Albert MS2. Neurology. 2017 May 2;88(18):1751-1758.

Partners

Abbott
Alzheimer's Association
AstraZeneca Pharmaceuticals, LP
Boehringer Ingelheim Pharmaceuticals, Inc.
Bristol-Myers Squibb Company
Eisai Inc
Eli Lilly and Company
Mayo Clinic
National Institute on Aging (NIA)
Pfizer Inc.

Contact

Rosa Canet-Aviles, Scientific Program Manager, Neuroscience, rcanet-aviles@fnih.org