Alzheimer’s Disease Clinical Trial Simulation Tool
This clinical trial simulation tool helps optimize clinical trial design for mild and moderate AD, using ADAS-cog as the primary cognitive endpoint. Access to the application for this tool is under construction.
Please get in touch by emailing cpadcore@c-path.org and we will contact you when development is complete.
Welcome to the information page for the mild and moderate Alzheimer’s disease clinical trial simulation tool developed by the CPAD modeling and simulation team.
Acknowledgements
CPAD would like to acknowledge the leadership and contributions from the following team members:
- Brian Corrigan (Pfizer)- Kaori Ito (Pfizer)
- James Rogers (Metrum Research Group)
- Daniel Polhamus (Metrum Research Group)
- Richard Meibach (Novartis)
- Richard Mohs (Lilly)
CPAD also acknowledges the effort from Drs. James Rogers and Daniel Polhamus from Metrum Research Group, in developing the additional instructional materials on the application of the tool, that are provided in the package.
Additional Information
A clinical trial simulation tool to help optimize clinical trial design for mild and moderate AD, using ADAS-cog as the primary cognitive endpoint
A drug-disease-trial model that describes disease progression, drug effects, dropout rates, placebo effect, and relevant sources of variability
Replacement for well-conducted trials with real patients.
A thorough description of the clinical trial simulation tool can be found here.
- Sample size calculations
- Determination of optimal trial durations and treatment effect measurement times
- Comparison of the sensitivity of competing trial designs to assumptions about the types of expected treatment effects (time to maximal effect, effects that increase or decrease over time)
- Determination of the most appropriate data analytic methods for novel trial designs
NOTE: researchers can apply this tool to answer further questions pertaining to clinical trial design and analysis
- For the proper application of this clinical trial simulation tool, the following background expertise and resources are recommended:
- Advanced-level knowledge of the statistical and methodological background behind drug-disease-trial models
- Advanced-level knowledge of the R programming language for statistical analysis
- Minimum system requirements:
- Operating System: Microsoft Windows XP SP3, 7, 8 / Mac OS X
- Processor: 2 gigahertz (GHz) Dual Core
- RAM: 2 gigabyte (GB) (32-bit) or 4 GB (64-bit)
- Hard disk space: 150 megabytes (MB)
- Graphics card: Microsoft DirectX 9 graphics device
Please take the time to explore the Read Me file
- Patient recruitment acRecruit(): Generates patients, their demographics, APOE4 distribution and baseline MMSE distribution
- Patient randomization acRandomize(): Assigns patients to treatment arms, time intervals and drug effects
- ADAS-cog simulation acRun(): Given previous conditions, simulates ADAS-cog scores (may include inter-study variability or dropouts)