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Is Alzheimer's Disease Drug Development Broken? What Must Be Improved
P-J Ousset1, J Cummings, J Delrieu
1Pierre-Jean Ousset. Gérontopôle, Department of Geriatrics, CHU Toulouse, Purpan University Hospital, Toulouse, France.
Alzheimer's disease (AD) clinical trials face significant challenges, with 99.6% of agents failing efficacy tests. Researchers propose streamlining trials through ready cohorts and harmonized procedures to accelerate drug delivery.
Area of Science:
- Neurology
- Clinical Trials
- Drug Development
Background:
- Alzheimer's disease (AD) drug development has a high failure rate, with 99.6% of agents failing primary endpoints between 2002-2012.
- Over 1,000 AD trials conducted (2000-2012) faced challenges including decreasing patient numbers per site and increased logistical demands.
Purpose of the Study:
- To discuss the evolution of Alzheimer's disease clinical trials over the past decade.
- To propose changes to streamline and enhance the efficiency of AD clinical trials.
Main Methods:
- Review of AD trial data from 2000-2012.
- Discussion and proposal of strategies by international AD researchers at a CTAD symposium.
Main Results:
- Biomarker use for enrichment or outcome measures increased screen failure and drop-out rates, extending trial duration and costs.
- High administrative and regulatory burdens limit recruitment efficiency, with only 13% of team time dedicated to it.
Conclusions:
- Streamlining recruitment through pre-established 'ready to go cohorts' using biomarkers and clinical measures is suggested.
- Harmonization of administrative and certification procedures, and evaluation of internet-based screening are recommended to improve AD drug development efficiency.
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