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Placebo effect in subjects with cognitive impairment
1Applied Pharmacometrics & Research LLC, Londonderry, NH, United States.
International Review of Neurobiology
|June 22, 2020
Summary
A model-based meta-analysis quantitatively models Alzheimer's disease (AD) progression and placebo effects. This approach aids clinical trial design and interpretation for AD research, offering a valuable tool for researchers.
Area of Science:
- Neuroscience
- Clinical Trials
- Biostatistics
Background:
- Alzheimer's disease (AD) clinical trials require understanding placebo response and disease progression.
- Disease severity (e.g., mild cognitive impairment, early/late AD) impacts progression rates, complicating trial interpretation.
- Accurate modeling is essential for effective AD drug development.
Purpose of the Study:
- To provide a quantitative understanding of placebo effects and disease progression in Alzheimer's disease.
- To develop a tool that aids in the design and interpretation of AD clinical trials.
- To leverage historical data for improved AD research outcomes.
Main Methods:
- A model-based meta-analysis approach was employed.
- Utilized all available historical data for Alzheimer's disease research.
- Developed a quantitative drug development tool (DDT) for AD.
Main Results:
- Achieved a quantitative understanding of placebo effects in AD.
- Established a clearer picture of AD disease progression across different stages.
- The developed DDT is the first quantitative tool for AD endorsed by FDA and EMA.
Conclusions:
- Model-based meta-analysis offers a robust method for analyzing AD progression and placebo effects.
- The AD DDT provides a valuable resource for accelerating drug development in Alzheimer's disease.
- This tool enhances the design and interpretation of clinical trials, improving research efficiency.
Keywords:
Alzheimer's disease (AD)Clinical trial simulation (CTS)Critical path institute (C-path)Disease progressionDrug development tool (DDT)Mild cognitive impairment (MCI)Model-based meta-analysis (MBMA)Placebo responseMore Related Videos
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