This Heart Treatment From The 1970s Could Also Improve Memory in Alzheimer's Patients

A little-known treatment for heart failure, developed more than half a century ago and refined in the '70s, may have legs as a potential therapy for Alzheimer's patients.

The treatment is called external counterpulsation (ECP), and it compresses the lower body using squeezable cuffs around the calves, lower thighs, and buttocks.

The non-invasive circulatory support device helps propel blood back to the heart, possibly improving arterial function on the way.

Today, ECP is approved by the United States Food and Drug Administration (FDA) for chest pain, acute myocardial infarction, and congestive heart failure, and yet it is rarely recommended or used for such purposes.

Other treatments are simply better established.

ECP may not be so old-fashioned, though.

In recent years, preliminary evidence suggests that ECP may have uses beyond the heart; it could also improve blood flow to the brain.

A randomized clinical trial has now shown that full-pressure ECP multiple times a week may provide benefits for those with early signs of dementia.

"Seventy-eight percent of patients with mild cognitive impairment or early Alzheimer's improved over their personal baseline after six months of this non-invasive treatment," says lead author Jack Juni from Renew Research, the company that owns the ECP medical device and funded the trial.

"On average, participants gained five points on standard cognitive scales – an improvement roughly equivalent to regaining one to two years' worth of lost function."

The trial included 190 patients with mild cognitive impairment or early Alzheimer's disease.

Compared to a placebo, ECP treatments had notable and sustained effects on cognition and daily activities.

These improvements were measured using tests of memory, attention, language, and reasoning, as well as assessments of everyday abilities like dressing, eating, and household tasks.

"The success of this treatment emphasizes the important role of the vascular system in clinical Alzheimer's disease," the trial authors conclude.

"ECP is a promising treatment for this otherwise devastating disease."

The involvement of private industry interests in scientific research is always a reason for skepticism, especially since robust evidence does not yet exist for ECP as a treatment for cerebrovascular diseases.

That said, there are good reasons to suspect that ECP might work to improve blood flow to the brain, and possibly brain function as a result.

In cases of dementia, blood flow to the brain is known to be reduced, with some regions receiving as much as 50 percent less blood flow.

What's more, hallmarks of Alzheimer's disease in the brain are often closely related to vascular health.

"An accumulating body of evidence indicates that vascular disease plays a meaningful role in the pathophysiology of AD and related dementias and represents a target for therapeutic intervention," write the authors of the recent trial, including neurologist Patrick Moriarty from the University of Kansas.

For years now, Moriarty has been investigating whether ECP can work to improve blood flow to the brain – and discloses in the paper that he's received support from Renew Research in the past.

To find out if the devices work for patients with early cognitive decline, Moriarty, Juni, and colleagues conducted a randomized, single-blind, controlled trial in the US.

As you can imagine, it's a bit hard to fake that someone's legs aren't being squeezed, so the 'placebo' was tricky to disguise.

As a compromise, half the group was randomized to receive full-pressure ECP synchronized with their heartbeats, while the other half received a sham treatment, involving low-pressure, unsynchronized pulsations.

In the end, the sham treatment still seemed to provide some benefits, but to a lesser extent.

In the full-pressure group, researchers report that 84 percent of patients showed improvements in cognitive function during the six-month treatment period.

"Compared to each individual's baseline, external counterpulsation significantly improved multiple measures of cognition and overall clinical assessment with minimal adverse events," the trial authors conclude.

"For the majority of patients, the observed changes represented improvements over baseline rather than simply a slowing of the rate of decline."

This does not mean that this device can slow the progression of Alzheimer's or mild cognitive impairment. But Renew Research is hopeful that the technology can improve some symptoms.

The first 35 sessions of ECP were delivered to patients 3 to 5 times per week for one hour. Then, after that, ECP sessions were delivered twice weekly.

At six months, the sessions were stopped, and yet patients continued to show cognitive benefits.

Six months after the last ECP treatment, 75 percent of those who received the real treatment still showed cognitive improvements from the start of the trial.

"To our knowledge," the authors write, "this is the first demonstration of a therapy causing an actual improvement over baseline in cognitive and functional abilities in this population."

More evidence is now needed among larger cohorts and for longer periods of time to figure out how ECP might improve brain function in cases of early cognitive decline, and how best to administer the treatment.

Participants in this trial were all diagnosed clinically with Alzheimer's, and not through blood biomarkers of the disease.

This leaves open the possibility that some were suffering from cognitive decline due to other causes, like vascular dementia.

This may have somewhat skewed the results.

Recently, the Renew Cerezen™ ECP device was certified in the European Union for treatment of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease.

But this does not mean that it shows robust evidence as a treatment. The device has not received the same permission by the US FDA.

"The benefit/risk profile is highly favorable, particularly compared to that of presently approved Alzheimer's disease therapies," the authors of the trial argue.

Last year, the company sent a letter to the FDA "over the continued delay" in approving its device "despite statistically significant, clinically meaningful results from a rigorously controlled, randomized US trial."

It's now in the FDA's hands.

The research has been published in American Journal of Alzheimer’s Disease & Other Dementias.