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The authors administered oral Dihexa to APP/PS1 transgenic mice (a standard amyloidopathy model of Alzheimers disease) and showed that brain AngIV levels were elevated relative to wild-type after Dihexa administration, that spatial learning and memory were restored on Morris water maze testing, that hippocampal neuronal density and synaptophysin protein expression were preserved, that astrocyte and microglial activation were reduced, and that pro-inflammatory cytokines (IL-1, TNF-) decreased while anti-inflammatory IL-10 increased

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The safety population included all subjects who received at least one dose of trial medication and had follow-up safety data