Yes, although newly certified in the EU for treatment of Alzheimer’s disease, counterpulsation technology has been used to treat cardiovascular diseases for decades with over ten million individual sessions logged. The safety record is exceptional. The most common adverse effect of Cerezen™ is chaffing of the skin under the cuffs. A review of data on over 486,000 treatments for various disorders revealed an adverse event rate of 0.007-1.3% per treatment. In a recent study of Cerezen™ treatment of 190 patients with early Alzheimer’s disease, there were no serious adverse events. This is in contrast to recent studies of anti-amyloid drugs which have found a 25-35% rate of brain swelling or bleeding (ARIA) and occasional drug-related deaths.
The concept of external counterpulsation – squeezing the legs between heartbeats to improve blood flow to the core body – was developed in the 1960s. Initially designed to help patients in heart failure, it was found to increase circulation to the heart, resulting in marked reductions in chest pain and improved exercise tolerance in angina patients. It was approved by the U.S. FDA in 1995 for treatment of heart failure and refractory angina. Subsequent research showed that counterpulsation causes improved blood throughout the body, including the brain, while also improving the ability of the arteries to increase blood flow to meet changing tissue needs.
Cerezen™ has advanced counterpulsation therapy to the point that it is now a transportable, exam-table sized device that runs from a single wall outlet. Heating, noise and other issues in older units have been eliminated resulting in comfortable, easily performed treatments.
Although much research has been devoted to treating protein buildup in the brain, 80-90+% of Alzheimer’s patients have reduced brain blood flow. In some patients this may be due to atherosclerosis (cholesterol plaques) while in others it may relate to a direct effect of the amyloid protein causing the small blood vessels of the brain to narrow. In these conditions, the brain receives insufficient oxygen and nutrients to function normally. Counterpulsation therapy has been shown to increase brain blood flow. This is hypothesized to be the one of the mechanisms of the improvement shown in Alzheimer’s patients treated with Cerezen™.
Cerezen™ has been certified in the EU under the EU MDR for treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease and for early Alzheimer’s disease. Together, these disorders are referred to as early Alzheimer’s disease. If you are having symptoms of memory loss, impaired reasoning or speech, personality changes or reduced ability to function on your own, you should contact your healthcare provider for a diagnostic evaluation.
Note: Cerezen™ has not been approved in the United States. Click here to ask your U.S. Representatives and FDA why?
Yes. Numerous studies have demonstrated cardiovascular effects of counterpulsation therapy and many studies have shown that counterpulsation improves brain blood flow. Studies of counterpulsation therapy in Alzheimer’s disease have shown improvement in brain function. Renew conducted a study of the Cerezen™ device in treatment of 190 patients suffering from early Alzheimer’s disease. Patients received 2-5 Cerezen treatments per week for 6 months. Those receiving standard Cerezen treatments showed highly significant improvements in both cognition (reasoning and memory) and independent functioning compared to those receiving sham treatments. Detailed findings are available here.
Studies of anti-amyloid drugs have been criticized for excluding patients who had common pre-existing conditions. A Mayo Clinic study found that only 8-17% of their Alzheimer’s patients would have qualified for an anti-amyloid drug trial. On the other hand, the Cerezen™ clinical trial found that 70% of patients met criteria for inclusion and treatment. The Cerezen™ study group was 62% female, 14% Black, and 18% Hispanic.
Your healthcare provider must determine that you may benefit from Cerezen™ treatment. Once treatment is prescribed, it is administered by a trained Cerezen™ technician/operator.
Cerezen™ sessions typically last 1 hour. The usual initial treatment regimen involves 3-5 treatment sessions per week for a total of 35 treatments. After that, a maintenance regime of 2 treatments weekly is recommended.
In the latest Cerezen™ study, patients were treated for a total of 6 months. As a group, brain function continued to improve throughout that period.