Open-access opportunities

Two organizations are teaming up to further support Alzheimer's research efforts in hopes of fighting those odds. The Critical Path Institute's (C-Path) Coalition Against Major Diseases (CAMD) has announced that it will integrate its Alzheimer's clinical trial data into the Global Alzheimer's Association Interactive Network (GAAIN) data portal. This portal is an open-access, big-data resource that makes Alzheimer's research data available for researchers on a global scale. Hosted by the Laboratory of Neuro Imaging at the Keck School of Medicine at the University of Southern California, GAAIN features data on more than 371,000 research participants from 22 data partners.

The data-sharing partnership between GAAIN and CAMD aims to accelerate the research cycle for Alzheimer's and dementia scientists around the world. CAMD will aid GAAIN as it broadens its data fields to further their use in data sharing, with increased functionality such as item-level clinical outcome assessments of cognitive performance (e.g. ADAS-COG and MMSE). The increased visibility and functionality of the GAAIN platform is expected to attract more researchers to the CAMD website while offering new sharing capabilities in Alzheimer's research networks.

“CAMD is one of several contributors who have agreed to partner with GAAIN to be a beta-site tester of new technologies they hope to implement in future, upgraded versions of the database,” says Dr. Stephen Arneric, executive director of CAMD, noting that the GAAIN network could be called “a federation of databases.”

C-Path's model, says Arneric, is to collect data from multiple sponsors among industry, academia or government labs. The institute establishes specifics with regards to how data should be captured as well as how it will be accessed and used, and by whom. Once they have the data in hand, he explains, “we map it to these common data standards that regulatory agencies really prefer to have it in, and that allows this aggregation of data across different trials.”

“Philosophically, we think that we as a society and a scientific community, we really have a responsibility to find better ways and faster ways to increase our understanding around what causes this disease, so having access to this type of information is critical,” Arneric tells DDNews. “The value proposition of sharing patient-level data from these clinical trials across the different sponsors, when it's done strategically—and what I mean by that is it's really targeted toward answering some scientifically credible questions and using the right statistical methods—can really lead to phenomenal advancements in developing better treatments, better clinical trial design. It fits our mission, and we think it's important that others help contribute to it.”

Looking ahead, he says that the organization is looking to contribute data from earlier stages of Alzheimer's disease, such as mild cognitive impairment and even pre-symptomatic stages.

"While we have a greater understanding now about the biological underpinnings that lead to dementia, there are still key questions that need to be answered in our search for treatments to stop or slow the progression of the disease," Dr. Maria Carrillo, chief science officer at the Alzheimer's Association, remarked in a statement. "Since it opened as a resource tool for the research community early last year, GAAIN has worked to link scientists with information and tools needed to advance research into the root causes of Alzheimer's and other dementia-causing diseases. The usable research data made available by CAMD through GAAIN will undoubtedly help the scientific community more efficiently tackle these diseases. We sincerely thank CAMD and its members for their contribution to and support of this critical data-sharing network."

And C-Path is not limiting its efforts to Alzheimer's disease, according to Arneric. The organization is already at work establishing databases for other central nervous system diseases, he notes, including The Critical Path for Parkinson’s Consortium, the Multiple Sclerosis Outcome Assessment Consortium and The Duchenne-Regulatory Science Consortium.

"Data sharing is the cornerstone for enabling advances in regulatory sciences that provide a gateway to new innovative treatments for patients with neurodegenerative disorders with impaired cognition and function," Arneric commented. "Our goal is to create drug development tools in collaboration with our members and regulators to accelerate the delivery of treatments that prevent or slow these diseases, so patients can maintain independence and health-related quality of life."