External counterpulsation uses inflatable cuffs around the calves, lower thighs and buttocks to compress the lower body and help propel blood back to the heart. It is approved by the US Food and Drug Administration for chest pain, acute myocardial infarction and congestive heart failure, but is rarely used, as other treatments are better established.
In the new trial, led by Jack Juni of Renew Research, which owns the ECP device and funded the study, patients with mild cognitive impairment or early Alzheimer's received either full-pressure ECP synchronized with their heartbeat or a sham treatment using low-pressure, unsynchronized pulsations.
The full-pressure group showed notable and sustained effects on memory, attention, language and reasoning, as well as everyday abilities such as dressing, eating and household tasks. Researchers reported that 84 percent of patients receiving full-pressure ECP showed improvements in cognitive function during the six-month treatment period, and 78 percent improved over their personal baseline. Six months after treatment stopped, 75 percent still showed improvements from the start of the trial.
"The success of this treatment emphasizes the important role of the vascular system in clinical Alzheimer's disease," the trial authors concluded. Neurology researchers at the University of Kansas, including Patrick Moriarty, who has received support from Renew Research in the past, contributed to the study.
Caveats remain. The trial was single-blind, and the sham treatment still provided some benefits, though to a lesser extent. Participants were diagnosed clinically rather than through blood biomarkers, so some may have had vascular dementia rather than Alzheimer's, which could skew results. The Renew Cerezen device has been certified in the European Union for mild cognitive impairment due to Alzheimer's, but has not received the same approval from the FDA. The company said last year it sent a letter to the FDA over the continued delay in approving its device despite statistically significant results. The findings were published in the American Journal of Alzheimer's Disease & Other Dementias.