Methods: This randomized, Phase 3, pivotal, single-blind, parallel design, multi-center study (NCT03721705) will assess the efficacy of RenewTM NCP-5 in patients with MCI due to AD or mild dementia (MD) of Alzheimer’s type at 16 sites in the USA, Europe, and Asia. Study participants (see Table 1 for key entry criteria) will be randomized 1:1 to receive a bolus of 35 60-minute RenewTM NCP-5 treatment sessions or sham therapy with 3–5 sessions per week. Following the initial 35 treatments, a maintenance period will begin with two treatment sessions per week for up to 24 weeks total. (Figure 2). The primary efficacy endpoint is the average of the change from baseline in Vascular Dementia Assessment Scale cognitive subscale (vADAS-Cog) at Weeks 12, 18, and 24. Safety is assessed throughout the study; other key assessments, including the measurement of CBF as a potential mechanistic index of therapeutic engagement through arterial spin labelling perfusion MRI, are presented in Figure 2. At month 12, all subjects will undergo a full assessment, and the sham group will have the option to enter an open-label extension.