Assessment reveals desperately slow period in drug development, with only eight new agents entering Phase I since 2016.
Cleveland Clinic’s annual analysis of Alzheimer’s disease drug development highlights an urgent need to increase the number of drugs entering the pipeline and to accelerate the drug testing and approval process.

Without changes, the likelihood of reaching the national goal to develop a meaningful therapy by 2025, as established by the Obama administration, is in jeopardy, according to the report. Alzheimer’s disease drug development: pipeline 2017 is Cleveland Clinic’s second annual review of Alzheimer’s disease drug development and appeared in the journal Alzheimer’s & Dementia: Translational Research & Clinical Trials Interventions (TRCI).

The comprehensive analysis – based on the federal website ClinicalTrials.Gov – reveals the immediate challenges of Alzheimer’s disease drug development, which include high drug failure rates, slow clinical trial recruitment and drug testing as well as a lack of sufficient funding. As the total cost of Alzheimer’s disease in the U.S. is expected to reach an unsupportable $1 trillion by 2050 with an estimated 100 million people worldwide being affected by the disease, Cleveland Clinic believes these factors must be addressed to increase the success rate and accelerate development of new therapies.

“The purpose of presenting our annual findings is to help better understand the status of Alzheimer’s disease drug development and to shed light on the critical need to enhance the drug testing process,” said Jeffrey Cummings, MD, director of Cleveland Clinic Lou Ruvo Center for Brain Health. “The Alzheimer’s disease pipeline is small with only 105 agents in the pipeline, and compared to the 2016 pipeline, there are only eight new agents in Phase I, illustrating a desperately slow period in Alzheimer’s disease drug development.”

Using a search of ClinicalTrials.Gov, Dr. Cummings – along with fellow authors Aaron Ritter, MD, director of Clinical Research at Cleveland Clinic Lou Ruvo Center for Brain Health; Kate Zhong, MD, Chief Strategy Officer of Global Alzheimer’s Platform; Garam Lee, PharmD, a clinical research pharmacist at Cleveland Clinic Lou Ruvo Center for Brain Health; and Touro University medical student Travis Mortsdorf – examined all clinical trials from 2016 to 2017 to find that under current circumstances, an agent must be in Phase II in order to possibly be approved by 2025. While there are promising agents in the pipeline that could be approved, it is evident that given the 99.6 percent drug failure rate, the aim to have a supply of drugs that can adequately respond to Alzheimer’s disease epidemic within the allotted timeframe is in uncertain.

Researchers suggest that repurposing drugs already approved by the FDA to treat other diseases can speed up the drug development timeline, and utilizing biomarkers to identify qualified clinical trial participants will expedite the recruitment process. The authors note that slow recruitment of participants to clinical trials is the largest impediment to developing new drugs for Alzheimer’s disease and a national effort to address this issue is required. Recommendations also include increasing investments in basic research to identify new therapies, while investments in transitional research can help support clinical trials and improve trial methods.