But researchers are plugging on, and sometime in the foreseeable future they may have a new tool to help them. A startup called Neurotrack is commercializing a sophisticated computer-based diagnostic tool that it says can determine whether an asymptomatic senior will develop Alzheimer’s within the next three to four years.
That, according to co-founder and CEO Elli Kaplan, would initially help pharmaceutical companies find the right patient pools for clinical trials of their experimental preventive drugs and ultimately enable more efficient drug development and evaluation.
Neurotrack tested its technology in a study funded by the National Institutes of Health and conducted at Emory University that tracked 92 asymptomatic participants between the ages of 53 and 67 over five years. To take the test, participants sat at a computer equipped with an eye-tracking device and viewed several sets of image pairs. Two identical images appeared side by side on the screen, and then the screen would go dark for a period of time between two seconds and two minutes. Then, a second set of images would come up — one being the previously shown image and the other being a new image. This went on for about 30 minutes.
What the company’s technology analyzed was how much time participants spent looking at the new image versus the old image in the second set of images. Healthy patients, Kaplan said, spent more time looking at the novel image; patients on the trajectory for Alzheimer’s showed a different pattern of looking that was more evenly spread between the two images.
If we use the Alzheimer’s Association statistic that one in eight people over age 65 has Alzheimer’s disease (PDF), we’d be talking about fewer than a dozen people in the study — a pretty small sample. But the numbers Kaplan rattled off were quite impressive.
“If you think of a test as being scored from zero to 100, of those people who scored below 50 on our test, 99 percent converted to Alzheimer’s disease in three to four years,” she said. “On the high end, anyone who scored above 67 didn’t convert. It does leave kind of a band in the middle, and those people we are continuing to follow.”
Researchers believe that the hippocampus is one of the first areas of the brain to be affected by Alzheimer’s disease, and it’s also the part of the brain that’s wired to make the recognition process that’s studied in the company’s test, Kaplan said.
Now that the company has some data, Kaplan said she’s working on raising funds, building a team and preparing to begin the regulatory approval process. In the meantime, “we’re rolling out the test in some big research hospitals and are also in conversations with pharmaceuticals,” she said.
There are plenty of companies who could benefit from this kind of test. Pfizer and Johnson & Johnson scrapped trials of bapineuzumab in patients with early signs of Alzheimer’s, but could still test that technology at an earlier stage of the disease. Roche is currently running a trial of gantenerumab in patients who have yet to develop dementia, and AstraZeneca and startups like Sonexa Therapeutics and AgeneBio have drug candidates further down the pipeline.
But Neurotrack also has plenty of competition from companies studying biomarkers, imaging techniques and other cognitive tests to detect early signs of the disease. Once preventive drugs are developed, these tests could have broader applications, as many researchers believe that early treatment is key to slowing the progression of the disease.
Kaplan said a second product is also in the works — one that would eliminate the need for an eye-tracking device by letting the test takers use just a mouse or track pad.