Renew Group is pleased to share that the clinical trial study conducted by Renew USA has been published. Please see full paper attached.
Treatment of Clinically Diagnosed Alzheimer's Disease by External Counterpulsation (ECP)
Juni et al., American Journal of Alzheimer's Disease & Other Dementias, 2026 [
Study Objective
The study evaluated whether External Counterpulsation (ECP)—a non-invasive vascular therapy already used in cardiovascular disease—could improve cognition and daily functioning in patients with early Alzheimer's disease (AD) and mild cognitive impairment (MCI) due to AD.
Study Design
- Randomized, multicenter, blinded, sham-controlled clinical trial.
- 190 participants with clinically diagnosed early AD (MCI due to AD or mild AD).
- Participants received either:
- Full-pressure ECP (150–300 mmHg), or
- Low-pressure sham treatment (25 mmHg).
- Treatment lasted 6 months, followed by 6 months of observation.
- Total follow-up: 12 months.
Key Findings
1. Significant Cognitive Improvement
Patients receiving full-pressure ECP demonstrated significantly greater improvement in cognitive performance compared with the control group.
VADAS-Cog (Primary Cognitive Endpoint)
- Full-pressure ECP: +9.95-point improvement
- Control: +5.22-point improvement
- Statistically significant (p = 0.005)
ADAS-Cog-14
- Full-pressure ECP: +6.16-point improvement
- Control: +2.74-point improvement
- Highly significant (p < 0.001)
MMSE
- Greater improvement observed in the ECP group at 6 months and sustained through 12 months.
2. Improved Daily Functioning
ECP recipients showed meaningful improvements in activities of daily living.
ADCS-ADL
- Full-pressure ECP: +2.57-point improvement
- Control: −0.49-point decline
- Significant difference (p = 0.036)
Importantly, each ADCS-ADL point reflects a change in independence or caregiver assistance requirements, making this clinically meaningful for patients and families.
3. Benefits Persisted After Treatment Ended
One of the most notable findings was the durability of benefit.
- ECP treatments stopped after 6 months.
- Improvements in cognition and daily functioning remained evident at the 12-month assessment, six months after treatment cessation.
4. Better Overall Clinical Status
Clinician assessments consistently favored full-pressure ECP.
- Odds of improvement on the Clinical Global Impression of Change (CGIC) were approximately 2–3 times higher in the ECP group across multiple follow-up visits.
5. Strong Safety Profile
Across:
- 190 patients
- 10,644 treatments
the study reported:
- No serious device-related adverse events
- No treatment withdrawals due to adverse events
- Most common side effect: mild, manageable skin irritation from compression cuffs
- No evidence of brain edema or hemorrhage on follow-up MRI scans.
Why This Matters
The authors propose that Alzheimer's disease is influenced not only by amyloid and tau pathology but also by vascular dysfunction and reduced cerebral blood flow. ECP may help by:
- Increasing cerebral blood flow
- Improving endothelial function
- Enhancing vascular reactivity
- Reducing inflammation
- Potentially improving brain perfusion over the long term.
This represents a fundamentally different therapeutic approach from current anti-amyloid drugs.
Key Takeaway
This randomized controlled trial demonstrated that External Counterpulsation (ECP) produced statistically significant improvements in both cognition and activities of daily living in patients with early Alzheimer's disease, with benefits persisting for at least six months after treatment ended and without serious safety concerns. The findings support ECP as a promising non-invasive, vascular-based therapeutic approach for early Alzheimer's disease and warrant further clinical investigation.