After decades of prominent failures, hope arose for a drug to slow the progression of Alzheimer’s disease (AD). After heightening expectations recently, Eisai Co. Ltd. (Tokyo) and Biogen Inc. (Cambridge MA) researchers showed that the high dose of their drug BAN2401 produced positive data in a mid-stage study with a statistically significant 30% slowing in the rate of decline compared to the placebo arm of the study at 18 months. The findings added a glimmer of hope but left plenty of reasons for doubt, Bloomberg says.
A day before the results for BAN2401 were unveiled in San Francisco, an executive from Eisai promised certainty–something that failed trials from a host of other drugmakers hadn’t been able to offer.
“It will be clear,” said Lynn Kramer, Eisai’s chief medical officer for neurology. “You won’t have any ambiguity.”
That wasn’t the case. One stock analyst, Robert W. Baird & Co.’s Brian Skorney, said there were “almost no reasonable conclusions to draw.”
The highest dose of BAN2401 showed statistically significant results in slowing Alzheimer’s decline, compared with patients who received a placebo. Treatment also lowered levels of amyloid in the brain, a hallmark of the disease, showing the drug was hitting its target. But patients getting lower doses didn’t have any cognitive benefit. After rising for weeks, the shares of both companies wound up getting hammered by the end of the week.
Meanwhile, another study was reported in San Francisco that got trampled beneath the hubbub about Biogen/Eisai’s AD news.
Most people are familiar with the steps they can take to lower their risk of heart disease and cancer. Choosing a diet carefully, exercising and quitting smoking have all been shown to lower the risk of these diseases. But when it comes to dementia–including dementia related to Alzheimer’s disease–scientists haven’t found many actionable steps that people can take to lower their risk. Genes play a prominent role in who develops dementia, especially Alzheimer’s, and age is also a dominant factor in the degenerative brain disorder, but neither are under human control.
In a presentation at the same Alzheimer’s meeting as Biogen and Eisai’s news, researchers reported some of the most encouraging evidence yet for one risk factor that people may be able to control to lower their risk of dementia: their blood pressure. In an extension of the SPRINT study which looked at how low blood pressure could prevent heart disease, scientists also found that lower blood pressure is linked to a lower risk of dementia.
In the SPRINT-MIND study, more than 9,300 elderly people who had had heart problems or were at higher risk of developing heart disease were randomly assigned to lower their blood pressure to either less than 120mmHg or 140mmHg systolic. (Current guidelines, revised in 2017 after the study began, now recommend that most people keep the upper number, or systolic pressure, under 130mmHg.) People who lowered their blood pressure to under 120mmHg lowered their risk of both mild cognitive impairment (MCI), the gateway to dementia, or probable dementia, by 15%, compared to people who lowered their blood pressure to just 140mmHg.
“Controlling blood pressure is not only good for the heart but good for the brain,” says Dr. Jeff Williamson, chief of geriatric medicine at Wake Forest School of Medicine, and one of the lead investigators in the trial. “This is the first intervention of any kind that has been proven in a randomized controlled trial to reduce the risk of mild cognitive impairment.”
More research needs to be done to explore the connection. But the results an encouraging sign that finally, there may be something people can do to help their brain, body and dementia risk.
“This is a very big deal,” said Maria Carillo, chief science officer at the Alzheimer’s Association. “Now we have evidence that lowering blood pressure is linked to brain health as well. Before, it was strongly suggested, but now we know from a study that it can make a difference.” (Ref: Time)
So, what’s the big deal about this blood-pressure study?
Put simply, for the first time in history, researchers have stumbled upon medicine that can reduce the risk of memory loss and dementia in your advancing years. Even better, most forms of the treatment are available in safe, inexpensive generic formulations. The shocker? These drugs have been around for decades since they’re widely used to lower blood pressure and ward off heart disease, The Washington Post reports.Steve's Take: It would be an amazing breakthrough if #Alzheimers can be slowed with #bloodpressure medication Click To Tweet
As the population ages, the incidence of cognitive impairment and dementia has surged. One in six women over the age of 55 and 10% of men are expected to develop dementia before they die. Alzheimer’s disease, the most common type, affects more than 5 million Americans and is the sixth leading cause of death in the country. And while the drug industry has spent billions of dollars trying to slow down memory loss once it begins, the efforts have been largely unsuccessful. Until now.
The Systolic Blood Pressure Intervention Trial, or SPRINT, was begun in 2010 to see if aggressively lowering blood pressure would reduce a range of health complications, including heart disease and dementia. The heart disease portion was halted five years later because the benefits were overwhelming. Researchers continued to track the cognitive function of 9,361 participants in a separate analysis called SPRINT-MIND through June.
“What is good for your heart is not only good for [just] your heart, but also good for your brain,” said Jeff Williamson, the lead researcher and chief of gerontology and geriatric Medicine at Wake Forest School of Medicine.
The researchers weren’t particular about what drug regimen the patients used, as long as they got to their goals. Those in the intensive treatment arm were expected to get below 120mmHg, the upper number in a blood pressure reading, while those in the standard treatment group aimed for 140mmHg.
Williamson compared the findings to car tires:
“You want to have the right pressure,” he said. “If it’s too high or too low, the tires can wear out quickly. With blood pressure, if it’s too high, the walls of the arteries can endure damage.”
The findings will allow people to take action in their own lives to lower their risk, with specific goals to aim for, said James Hendrix, director of global science initiatives at the Alzheimer’s Association. Many people aren’t at recommended blood pressure levels, he said, and evidence that better control helps the heart and the brain may push them into action.
“People may do all the right things and still develop dementia, but this may give them more time,” Hendrix said. “It may give another five or 10 years with a healthy brain.”
While Eisai and Biogen are predictably bullish with their expectations for a long-awaited breakthrough (and payoff), their time, money and research efforts will focus on finding ways to speed the last stages of studies and get accelerated reviews from global agencies. Doctors are less sanguine, saying longer, larger trials are needed to definitively answer whether BAN2401 works.
Note to self: Ask my cardiologist if lowering my blood pressure, even though it’s not dangerously high at present, is something I can do safely to lower my dementia/AD risk. That’s a no brainer.