NeuroEPO in mild‐to‐moderate Alzheimer's disease: Human/Human trials: Cognitive enhancement. (7th December 2020)

• Record Type: Journal Article
• Authors: Pérez, Leslie; Sosa, Saily; Bringas, Giosmany; López, Danay; Valenzuela, Carmen; Peñalver, Ana Ivis; Dalmau, Evelio; Rodríguez, Teresita; Urrutia, Nelky
• Is Part Of: Alzheimer's & dementia. Volume 16(2020)Supplement 9
• Page Start: n/a
• Page End: n/a
• Publication Date: 2020-12-07
• Subjects: Alzheimer's disease -- Periodicals; Alzheimer Disease -- Periodicals; Dementia -- Periodicals; Démence; Maladie d'Alzheimer; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.83
• DOI: 10.1002/alz.036167
• Languages: English
• ISSNs: 1552-5260

Abstract

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.