Whitepaper: Accelerating drug discovery for Alzheimer’s disease: best practices for preclinical animal studies

In this whitepaper, ADDF partner with Charles River and an expert advisory panel of academic, industry and government scientists to make recommendations on best practices for animal studies testing investigational AD therapies…

wAnimal models have contributed significantly to our understanding of the underlying mechanisms of Alzheimer’s disease (AD). As a result, over 300 interventions have been investigated and reported to ameliorate pathological phenotypes and/or improve behavior in AD animal models.

To date, however, these findings have not resulted in target validation in humans and successful translation to disease-modifying therapies. Challenges in translating preclinical studies to clinical trials include the inability of mouse models to adequately recapitulate the human disease, variations in breeding and colony maintenance practices, lack of standards in design, conduct and analysis of animal trials, and publication bias due to under reporting of negative results in the scientific literature.

The quality of animal model research on novel therapeutics can be improved by bringing the rigor of human clinical trials to animal studies. To this end, the Alzheimer’s Drug Discovery Foundation (ADDF) partnered with Charles River Discovery Research Services and convened an expert advisory panel of academic, industry and government scientists to make recommendations on best practices for animal studies testing investigational AD therapies. By promoting best practices, these recommendations can improve the methodological quality and predictive value of AD animal studies and make the translation to human clinical trials more efficient and reliable.