NeuroEPO plus (NeuralCIM®) in mild-to-moderate Alzheimer’s clinical syndrome: the ATHENEA randomized clinical trial
Keywords:
randomized controlled trial, neuroEPO, Alzheimer’s disease, neuroprotectiveAbstract
Introduction: There are limited efficacious treatments for Alzheimer disease. Cuba has difficult access to these treatments. NeuroEPO plus is an excellent candidate for the treatment of this disease.
Objective: To assess the efficacy and safety of neuroEPO plus.
Methods: This was a double-blind, randomized, placebo-controlled, phase 2-3 trial involving persons 50 years of age or older with mild-to-moderate Alzheimer clinical syndrome. Participants were randomized 1:1:1 ratio to receive neuroEPO plus 0.5 mg or 1.0 mg or placebo intranasally 3 times a week for 48 weeks. The primary efficacy variable was the change on the 11-item cognitive subscale of the Alzheimer Assessment Scale score from baseline to 48 weeks (higher scores indicate greater impairment).
Results: A total of 174 participants were enrolled and 170 were treated (57 in neuroEPO plus 0.5 mg, 56 in neuroEPO plus 1.0 mg and 57 in placebo group). Mean age, 74.0 years; 121 (71.2%) women and 85% completed the trial. The median change in 11-item cognitive subscale of the Alzheimer Assessment Scale score at 48 weeks was -3.0 (95% Confidence Interval -4.3 to -1.7) in the 0.5 mg neuroEPO plus group, -4.0 (95% Confidence Interval -5.9 to -2.1) in the 1.0 mg neuroEPO plus group and 4.0 (95% Confidence Interval 1.9 to 6.1) in the placebo group. The difference neuroEPO plus 0.5 mg vs. placebo was equivalent to 7.0 points (95% Confidence Interval 4.5-9.5) p = 0.000. The difference between the neuroEPO plus 1.0 mg vs. placebo was 8.0 points (95% Confidence Interval 5.2-10.8) p = 0.000.
Conclusions: NeuroEPO plus significantly improved cognitive evaluation at 48 weeks, with a very good safety profile in patients with clinical Alzheimer's syndrome.
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