NeuroEPO plus (NeuralCIM^®) in Alzheimer's disease: Post-trial observational follow-up study

BackgroundNeuroEPO plus is a recombinant erythropoietin with a sialic acid content like that produced by astrocytes, lacking the hematopoietic activity of conventional erythropoietin.ObjectiveTo evaluate the efficacy and safety of treatment with neuroEPO plus.MethodsIt was a post-trial observational follow-up study with four groups, NE: subjects who continued treatment with neuroEPO plus after trial, PB-NE: subjects who received a placebo during the trial and then receive neuroEPO plus, NE-CTRL: subjects who received neuroEPO plus during the trial and then interrupted treatment and CTRL: subjects who were never treated. NeuroEPO plus was administrated three times a week nasally. The primary outcome was changed from baseline in the score on the11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog11) at 96 weeks. Secondary outcomes included Global Deterioration Scale, Montreal Cognitive Assessment, Neuropsychiatric Inventory, and Lawton Instrumental Activities of Daily Living Scale.ResultsThe adjusted median change from baseline in the ADAS-Cog11 score at 96 weeks was -6.0 in NE group and 11.0 in the CTRL group (difference, 21.0; 95% confidence interval [CI], 14.6-27.4; p = 0.000), -1.0 in the PB-NE (difference, 15.4; 95% CI, 9.0-21.8; p = 0.000) and 4.0 in the NE-CTRL (difference, 8.3; 95% CI, 1.4-15.2; p = 0.011). The results for secondary outcomes showed statistically significant differences.ConclusionsSubjects who continued or started treatment with neuroEPO plus stabilized or slowed down the progression of the disease. These results and the method of drug administration, make neuroEPO plus an attractive option to consider for Alzheimer's disease patients.