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Background With no cure or effective treatment, the prevalence of patients with Alzheimer’s disease (AD) is expected to intensify, thereby increasing the social and financial burden on society. Light-based 40 Hz brain stimulation is considered a novel treatment strategy for patients with AD that may alleviate some of this burden. This project will utilize a novel Light Therapy System (LTS). The LTS uses Invisible Spectral Flicker for non-invasive induction of 40 Hz neural activity. This protocol describes a trial evaluating the efficacy and safety of a light-based 40 Hz brain stimulation, in patients with mild-to-moderate AD. Methods 62 patients with mild-to-moderate AD will participate in a randomized, double-blinded, placebo-controlled, parallel-group, and single-center trial. The participants will partake in an enrollment period of 1 month, an intervention period of 6 months, and a 1.5-month post-interventional follow-up period. At week 0, patients will be randomized to either active or placebo intervention. The primary endpoints will be the change of total gamma power at 40 Hz from baseline to weeks 26 and 32 with and without concomitant stimulation with the device. Discussion This protocol describes a randomized, double-blinded, placebo-controlled clinical trial that may increase the understanding of the effect of gamma oscillations in the human brain, and how it could be utilized as a novel and important tool for the treatment of AD. The effect is measured through a large, multidisciplinary assessment battery. Trial registration: ClinicalTrials.gov (NCT05260177). Registered on March 2, 2022. |
