Announcements Underscore Efforts to Identify, Treat Alzheimer's Disease at Earlier Stages
This is an important week in the battle against Alzheimer’s disease. That’s because there’s a major move toward diagnosing and treating Alzheimer’s in its earliest stages.
The U.S. Food and Drug Administration (FDA) has announced plans to ease the approval process for experimental drugs related to Alzheimer’s disease. This move is designed to move the agency’s focus to the disease’s early stages.
In a column in The New England Journal of Medicine, FDA officials reported that this decision was made because of mixed results in the current effort aimed at over dementia. The column notes that while positive findings such as discoveries that have unmasked the complex ways that that the disease progresses, there are negative issues as well. For instance, researchers have had disappointing news in discovering drugs to slow the onslaught. “Despite all best efforts to translate mechanistic insights concerning Alzheimer's disease into new drug products, several candidate agents have failed to demonstrate efficacy in large, well-designed, phase 3 clinical trials of late-stage disease,” the FDA officials wrote.
Why may these disappointing results have happened? The FDA officials suggest that one theory is that the intentions may have undertaken too late in that the person’s brain was irrevocably compromised.
The FDA officials noted that moving its efforts toward early stages of the disease may be difficulty since it can be difficult to assess the disease at this point. However, the FDA wants to extend the range of focus to healthy people who are at risk for the disease, but not showing any signs. The feeling is that these people could benefit from preventive therapies.
“As the focus of drug development has shifted to earlier stages of Alzheimer's disease, many new and challenging scientific questions have emerged, and the regulatory framework under which such therapies are evaluated should evolve accordingly,” the FDA officials stated. “The FDA remains committed to innovative approaches to the evaluation of drugs that are in clinical development. Effective treatments for the devastating disorder that is Alzheimer's disease are urgently needed, as the world's population continues to age.”
So how are they going to find people in the earliest stages? That brings me to a second development of this week.
Emerging Technology to Diagnose Alzheimer's Earlier
Because of its innovation in diagnosing Alzheimer's at a very early stage, Neurotrack, a technology startup, took first health prize at the 2013 South by Southwest (SXSW) startup accelerator. The company reports that its new technology actually can diagnose Alzheimer’s disease up to six years before symptoms emerge and has a 100 percent accuracy rate in making these diagnoses.
Neurotrack, which was developed in collaboration with neuroscientists who now are at Atlanta’s Emory University, uses a computer-based visual cognitive test. There are two versions of the program. One uses an infrared camera while the other uses a computer mouse. The program actually tracks and analyzes eye movements as a person compares new and familiar images that appear briefly on a screen. The results are then scored. Neurotrack Chief Executive Officer Elli Kaplan reports that 100 percent of subjects who scored below 50 percent on the test have within six years received a diagnosis of Alzheimer’s. In comparison, everyone who scored above 67 percent has not been diagnosed with this disease.
"By monitoring the way a person moves their eyes, and watching how they view novel images versus familiar images, we're able to detect perturbations that exist on the hippocampus," Kaplan said. "Every human being has an instinctive preference for novelty and that's one of the things that we are testing.” This technology focuses on the hippocampus for two reasons – because it is the part of the brain responsible for memories and because it is the first part of the brain affected by Alzheimer’s disease.
Taken together, the FDA announcement and this new technology offers new hope for people like me who are currently health but are worried about a future diagnosis of Alzheimer's disease. Now if pharmaceutical companies can use new technologies such as Neurotrack to identify drugs that will prevent or slow the disease, we’ll all be in good shape. Keep your fingers crossed!
Primary Sources for This Sharepost:
AARP. (2013). FDA to ease rules for new Alzheimer’s drugs.
Counsel & Heal. (2013). Neurotrack to detect Alzheimer’s years before debilitating symptoms appear wins SXSW health prize.
Katz, R. (2013). Trying to meet a desperate need: Treatments for Alzheimer’s disease. U.S. Food and Drug Administration.
Kozauer, N. & Katz, R. (2013). Regulatory innovation and drug development for early-stage Alzheimer’s disease. The New England Journal of Medicine.
Medical Press. (2013). Technology to detect Alzheimer’s takes SXSW prize.
U.S. Food and Drug Administration. (2013). Guidance for industry. Alzheimer’s disease: Developing drugs for the treatment of early stage disease.