Objective:
To evaluate the efficacy of full-pressure external counterpulsation (ECP) compared to low-pressure treatment in improving cognition and activities of daily living in patients with mild cognitive impairment due to Alzheimer disease or mild Alzheimer disease.
Approach:
- Study Design: A 12-month, multicenter, randomized, single-blind trial involving 190 patients aged 55 to 85 years.
- Intervention: Patients were randomly assigned to full-pressure ECP (150 to 300 mmHg) or low-pressure treatment (approximately 25 mmHg), receiving 35 sessions over 7 to 12 weeks followed by maintenance sessions.
- Outcome Measures: Primary efficacy was assessed using the Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog) score, with additional assessments including ADAS-cog 14 and Mini-Mental State Examination.
Key Findings:
- The time-averaged VADAS-cog score improved by 9.95 points in the full-pressure group compared to 5.22 points in the low-pressure group.
- At 12 months, the full-pressure treatment group showed a 9-point improvement from baseline, while the low-pressure group showed a 3-point decline.
- Activities-of-daily-living scores improved by 2.57 points in the full-pressure group and declined by 0.49 points in the low-pressure group.
Limitations:
- Potential tester bias due to lack of blinding for site personnel administering primary efficacy outcomes.
- Placebo and practice effects could not be excluded.
- Follow-up imaging for amyloid-related abnormalities was incomplete.
Sources:
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