Alzheimer’s Disease and Clinical Research

butler-adamBy Adam Butler, Sr. Vice President, Strategic Development at Bracket

Alzheimer’s disease is deadly and difficult, and its impact is enormous. Understanding the scope of how the disease affects people is difficult. Every year, the Alzheimer’s Association compiles a report that attempts to quantify the public health impact of the disease, and it’s an essential resource for helping every stakeholder understand the magnitude of the problem.

The 2016 report is now available, and it includes a comprehensive data set that illustrates the prevalence of the disease, includes pertinent information on the caregivers who bear most of the burden of the disease, and describes both the cost of the disease to health care systems, but also how it can impact patients and their families directly.

roundtable summary

The Alzheimer’s Association has been at the forefront of advocating for better care for patients and their caregivers, but also advocating for more and better research into the disease. There are only limited treatments available for patients with the disease, and the R&D track record has been miserable for the last 15 years. Investment in trials investigating new treatments is at an all-time high, and there are encouraging new approaches now being tested.

One of the ways the Alzheimer’s Association has supported this research effort is through the work of the Research Roundtable. Roundtable members “seek to facilitate the development and implementation of new treatments for Alzheimer’s disease by collectively addressing obstacles to research and development, clinical care and public health education.” Bracket is proud to be a member of the Research Roundtable, which meets semi-annually to gather R&D leaders from across academia and industry to organize new approaches to conducting this research. This gives drug developers, who in some cases may be competing with each other to advance treatments, a pre-competitive forum to discuss the science in a way that will be beneficial to everyone. This is a significant accomplishment, and the Roundtable has published dozens of papers and reports on their progress.

Alzheimer’s disease clinical trials are challenging. Bringing patients and their caregivers into a research program is difficult. The progression of the disease requires clinical trials that run for years to try and properly understand how treatments work. Trials fail, repeatedly. In some cases this is because our treatments may not be working. But in some cases, it may be because the outcomes used in these trials are difficult, and the data collected with them is noisy.
alz roundtable blog bda sampleAt Bracket, we have developed over the years a particular expertise in this area. As these trials started becoming larger, and more global, 15 years ago, initial approaches to improving the use of clinical outcomes assessments in these trials were focused on finding experienced sites and training clinical raters extensively. But the limitations of this approach were obvious, and at Bracket we quickly shifted focus to new methods that could help.

ecoa results

Today, Bracket uses an advanced Electronic Clinical Outcomes Assessment tool called the Rater Station to collect patient and caregiver data in clinical trials. In addition, our Blinded Data Analytics and Quality Assurance programs combine the statistical analysis of raw and derived data with rigorous clinical assessment/interpretation of the results in order to identify areas of concern.

The support of collaborative organizations like the Alzheimer’s Association has been essential to how Bracket has evolved over the years. They provide a forum for discussing and evaluating the best approaches to advancing these research efforts, and Bracket is proud to be a supporter.