Limitations
Alzheimer’s disease
This study has some limitations. The sample size was relatively small. The data collection was done for 48 weeks. The cerebral perfusion was evaluated in a reduced number of patients. The trial was conducted during the COVID-19 pandemic and encountered obstacles including missed doses, delayed assessments, and intercurrent illnesses. There are no pharmacokinetic studies in AD subjects. However, evidence for the presence of neuroEPO plus in the CSF has been observed when neuroEPO plus was administered in subjects with SCA2 [Additional trials of neuroEPO plus include a 78-week phase 3 comparing neuroEPO plus vs. donepezil or the combination, where the clinical diagnosis will be complemented with the determination of β-amyloid in CSF (RPCEC number, RPCE00000409) and a 104-week phase 3 long-term extension trial (RPCEC00000410) in mild-to-moderate Alzheimer’s disease patients.