NeuroEPO in mild‐to‐moderate Alzheimer’s disease

Abstract

Background NeuroEPO, is a nasal pharmaceutical solution of recombinant human erythropoietin with low sialic acid. Methods Phase II/III, prospective, double‐blind, randomized, placebo‐controlled, multicenter with adaptive design clinical trial involving patients with mild‐to‐moderate Alzheimer’s. NeuroEPO or placebo, with doses 0.5 or 1.0 mg 3 times a week for 48 weeks was administered by nasal route. The primary outcome measure was a score on the 11‐item cognitive subscale of the Alzheimer’s disease Assessment Scale (ADAS‐cog11, with scores ranging from 0 to 70 and higher scores indicating greater impairment). Secondary outcome measures were: % annual change of hippocampus volume by magnetic resonance imaging (MRI) studies, neuropsychological scales and adverse events. An interim analysis was made according to the criteria as established in the protocol. Results Per‐protocol‐analysis, 69 patients finished one year of treatment. 49% of the patients showed improvement, 9% remained stable and 42% got worse, according to the ADAScog11 score. Regarding the hippocampus % annual change, 48 patients were analyzed. 58% of those patients remained stable and 42% witnessed a decline in the hippocampus volume compared with the % annual change of patients with AD (∼4.4%). No serious adverse events related with NeuroEPO were reported. Conclusions NeuroEPO improve clinical outcomes in patients with Alzheimer’s disease with good security profile. Therefore, it could be useful in the treatment of this kind of patients.

Effect of intranasal administration of neuroEPO in the histological structure of the olfactory mucosa of rats Wistar

“…Preclinical studies have demonstrated the effects of NeuroEPO on CNS protection in models of Alzheimer's, stroke, and glutamate-induced excitotoxicity (6)(7)(8)(9). In clinical studies, intranasal administration has shown to be safe and well tolerated in healthy volunteers and shows favorable effects with clinical improvement in patients with Parkinson's disease, Alzheimer's, and spinocerebellar ataxia type 2 (10)(11)(12)(13)(14). In addition, NeuroEPO has beneficial effects on glycemia and reproduction in diabetic rats.…”