August 29, 2017
Annual Review of Alzheimer’s Investigational Agents Demands Action
In June, the Cleveland Clinic Lou Ruvo Center for Brain Health released its annual report on Alzheimer’s disease (AD) drug development. Based on a survey of all trials reported on the website ClinicalTrials.Gov, the authors found an urgent need to increase the number of agents entering the AD pipeline to accelerate the drug testing and approval process.
According to the authors – the likelihood of reaching the national goal to develop a meaningful therapy by 2025 as established by the Obama Administration – is in jeopardy. The paper, “Alzheimer’s Disease Drug Development: Pipeline 2017,” is the Lou Ruvo Center for Brain Health’s second annual review of AD drug development and appears in the journal Alzheimer’s & Dementia: Translational Research & Clinical Trials Interventions (TRCI).
The comprehensive analysis reveals the immediate challenges of AD drug development:
- High drug failure rates
- Slow clinical trial recruitment
- A lack of sufficient funding
The total cost of AD in the U.S. is expected to reach an unsupportable $1 trillion by 2050 with an estimated 100 million people worldwide affected by the disease.
“The AD 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 AD drug development,” says Jeffrey Cummings, MD, ScD, Director, Cleveland Clinic Lou Ruvo Center for Brain Health and the paper’s lead author.
While there are promising agents in the pipeline that may prove successful, the high failure rate of candidate agents (99.6%) makes the goal of having a new drug that can adequately respond to the AD epidemic by 2025 uncertain.
Dr. Cummings and his fellow authors suggest that repurposing drugs already approved by the FDA to treat other diseases can speed up the drug development timeline, and utilizing biomarkers or hallmarks of AD to identify qualified clinical trial participants will expedite the recruitment process.
You can help
The largest impediment to developing new drugs for AD is slow recruitment of participants to clinical trials.
If you or a family member are interested in participating in a clinical trial for the prevention of Alzheimer’s, please contact us at HealthyBrains@ccf.org.