1970s heart treatment shows cognitive gains in early Alzheimer's trial

External counterpulsation improved cognition in most patients in a six-month study, though questions remain

By LineZotpaper
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A randomized trial has found that external counterpulsation (ECP), a non-invasive heart treatment developed in the 1970s, improved cognition and daily function in patients with mild cognitive impairment or early Alzheimer's disease. The company-funded study of 190 patients reported that 78 percent improved over their personal baseline after six months, with an average gain of five points on standard cognitive scales.

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.

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Analysis

Why This Matters

  • If confirmed, ECP would offer a non-drug, non-invasive option for early cognitive decline, with a reportedly favorable benefit/risk profile compared with approved Alzheimer's therapies.
  • The results strengthen the argument that vascular health plays a meaningful role in Alzheimer's disease and related dementias.
  • A regulatory decision is pending: the device is EU-certified for this use but not yet FDA-approved.

Background

External counterpulsation has been used for decades to improve circulation in heart failure patients by squeezing the lower body in time with the heartbeat. Brain blood flow is known to be reduced in dementia, with some regions receiving up to 50 percent less blood, and vascular problems are increasingly linked to Alzheimer's pathology. Renew Research is now seeking to extend the treatment's approved uses to early cognitive decline.

Key Perspectives

Trial authors: They argue that ECP significantly improved multiple measures of cognition and overall clinical assessment compared with each patient's baseline, with minimal adverse events, and that the benefit/risk profile is highly favorable. Skeptics: The involvement of private industry in the research is a reason for caution, robust evidence does not yet exist for ECP as a cerebrovascular treatment, and the lack of biomarker-based diagnosis means some participants may have had vascular dementia, potentially skewing results. Regulators: The FDA has not approved the device for Alzheimer's or mild cognitive impairment. Renew Research sent a letter to the agency last year over the continued delay, and the decision now rests with the FDA.

What to Watch

  • Whether the FDA approves the Renew Cerezen device for mild cognitive impairment or mild Alzheimer's disease.
  • Results from larger, longer-term studies involving biomarker-confirmed Alzheimer's patients.
  • Whether cognitive benefits persist beyond the six-month post-treatment period, as the trial reported for 75 percent of treated patients.

Sources

Checked

12 claims in this story checked against 1 source: 11 supported.

Show each claim
  1. Partly supportedThe heart treatment was developed in the 1970s.ScienceAlert: “A little-known treatment for heart failure, developed more than half a century ago and refined in the '70s”
  2. SupportedMost patients improved cognitively during the six-month study.ScienceAlert: “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”
  3. SupportedThe randomized trial found improvements in cognition and daily function among patients with mild cognitive impairment or early Alzheimer's disease.ScienceAlert: “Compared to a placebo , ECP treatments had notable and sustained effects on cognition and daily activities.”
  4. SupportedThe study included 190 patients.ScienceAlert: “The trial included 190 patients with mild cognitive impairment or early Alzheimer's disease.”
  5. SupportedPatients gained an average of five points on standard cognitive scales.ScienceAlert: “On average, participants gained five points on standard cognitive scales – an improvement roughly equivalent to regaining one to two years' worth of lost function.”
  6. SupportedSeventy-eight percent improved over their personal baseline after six months.ScienceAlert: “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”
  7. SupportedThe trial authors concluded, “The success of this treatment emphasizes the important role of the vascular system in clinical Alzheimer's disease.”ScienceAlert: ““The success of this treatment emphasizes the important role of the vascular system in clinical Alzheimer's disease,” the trial authors conclude .”
  8. SupportedEighty-four percent of patients receiving full-pressure ECP showed cognitive improvements during the six-month treatment period.ScienceAlert: “In the full-pressure group, researchers report that 84 percent of patients showed improvements in cognitive function during the six-month treatment period.”
  9. SupportedSix months after the last ECP treatment, 75 percent still showed cognitive improvements from the start of the trial.ScienceAlert: “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.”
  10. SupportedThe trial was single-blind, and the sham treatment provided some benefit, but less than full-pressure ECP.ScienceAlert: “Moriarty, Juni, and colleagues conducted a randomized, single-blind, controlled trial in the US.”
  11. SupportedParticipants were diagnosed clinically rather than through blood biomarkers, so some may have had vascular dementia, potentially skewing the results.ScienceAlert: “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.”
  12. SupportedThe study was funded by Renew Research, which owns the ECP device.ScienceAlert: “says lead author Jack Juni from Renew Research, the company that owns the ECP medical device and funded the trial.”

Zotpaper

Written by June Katz on the Science desk. Claims checked by Ines Fairley, verification. Read for legal risk by Marcus Hale, legal. Edited by Angus Burke, chief sub.

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