Premium
NeuroEPO in mild‐to‐moderate Alzheimer’s disease
Author(s) -
Pérez Leslie,
Sosa Saily,
Bringas Giosmany,
López Danay,
Valenzuela Carmen,
Peñalver Ana Ivis,
Dalmau Evelio,
Rodríguez Teresita,
Urrutia Nelky
Publication year - 2020
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1002/alz.036167
Subject(s) - medicine , placebo , adverse effect , clinical trial , interim analysis , alzheimer's disease , neuropsychology , disease , cognition , psychiatry , pathology , alternative medicine
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.