External counterpulsation devices that wrap inflatable cuffs around the lower body to pump blood toward the heart have improved cognitive scores in patients with early Alzheimer’s disease, according to a randomized clinical trial published in the American Journal of Alzheimer’s Disease & Other Dementias. Following six months of therapy, 78% of the trial participants surpassed their initial baseline, picking up an average of five points on standard cognitive assessments—roughly mirroring the recovery of one to two years of lost mental capability.
Eighty-four percent of patients showed cognitive improvements
The trial evaluated 190 patients with mild cognitive impairment or early Alzheimer’s disease. Participants were split to receive either full-pressure external counterpulsation synchronized with their heartbeats or a sham treatment using low-pressure, unsynchronized pulsations. Researchers measured changes using tests of memory, attention, language, and reasoning alongside assessments of everyday abilities like dressing, eating, and household tasks. In the full-pressure group, 84 percent of patients showed improvements in cognitive function over the six-month treatment period. Six months after the final session, 75 percent of those who received the real treatment still showed cognitive improvements compared to the start of the trial. Lead author Jack Juni from Renew Research stated that participants gained five points on standard scales.
Physical compression helps propel blood flow to the brain
Blood flow to the brain in dementia patients is often reduced, with some regions receiving as much as 50 percent less blood flow. The trial authors, including Patrick Moriarty from the University of Kansas, concluded that the treatment’s success highlights the important role the vascular system plays in clinical Alzheimer’s disease. Moriarty has investigated whether external counterpulsation can enhance blood flow to the brain, disclosing past support from Renew Research in the paper. Because external counterpulsation physically compresses the calves, lower thighs, and buttocks, it helps propel blood back to the heart, possibly improving arterial function on the way.
European Union certifies device for Alzheimer's disease treatment
While the US Food and Drug Administration has approved external counterpulsation for chest pain, acute myocardial infarction, and congestive heart failure, it is rarely recommended or used for such purposes because other treatments are better established. Regulatory authorities in the European Union have granted certification to the Renew Cerezen™ ECP system for addressing mild cognitive impairment linked to Alzheimer’s disease, as well as mild forms of the condition itself. It has not received the same permission by the US FDA. Renew Research sent a letter to the FDA last year over the continued delay in approving its device despite the randomized US trial results.
Squeezable cuffs deliver treatment in synchronization with heartbeats
How is external counterpulsation administered to patients?
Patients receive the treatment through squeezable cuffs wrapped around their calves, lower thighs, and buttocks that inflate in synchronization with their heartbeats. The protocol in the trial delivered the first 35 sessions three to five times per week for one hour, followed by twice-weekly sessions for a total of six months.
What was used as a placebo in the trial?
Because researchers found it difficult to disguise whether a patient’s legs were being squeezed, they used a sham treatment consisting of low-pressure, unsynchronized pulsations for the control group. The trial authors noted that the sham treatment still seemed to provide some benefits, but to a lesser extent.
Has the device received FDA approval for Alzheimer’s?
No, the device has not received the same permission by the US FDA for Alzheimer’s disease treatment. The company sent a letter to the FDA last year over the continued delay in approving its device despite the randomized US trial results.
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