AUTHOR=Yokoi Yuma , Inagawa Takuma , Yamada Yuji , Matsui Makoto , Tomizawa Asumi , Noda Takamasa 

TITLE=A randomized sham-controlled trial of transcranial and intranasal photobiomodulation in Japanese patients with mild cognitive impairment and mild dementia due to Alzheimer’s disease: a protocol

JOURNAL=Frontiers in Neurology

VOLUME=Volume 15 - 2024

YEAR=2024

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1371284

DOI=10.3389/fneur.2024.1371284

ISSN=1664-2295

ABSTRACT=Introduction Photobiomodulation (PBM) is a novel strategy for cognitive enhancement by improving brain metabolism and blood flow. It is potentially beneficial for patients with Alzheimer's disease (AD). We present a study protocol for a randomised controlled trial designed to evaluate the efficacy and safety of PBM.This is a single-centre, parallel-group, randomised, sham-controlled study. We enrol patients with mild cognitive impairment or dementia due to AD and assigned them to receive either active or sham stimulation at home for 12 weeks, with three sessions per week (20 minutes each). The stimulation involves invisible near-infrared light delivered by five applicators (one in a nostril, one on the frontal scalp, and three on the occipital scalp). The primary outcome will be the mean change in the Alzheimer Disease Assessment Scale-cognition from baseline to Week 12. We will also measure cognitive function, activity of daily living, behavioural and psychological symptoms, and caregiver burden. We will collect data at clinics at baseline and Week 12 and remotely at home. We estimate a sample size of 30 (20 active and 10 sham) based on an expected mean difference of -6.9 and an SD of 4.8. We use linear models for the statistical analysis.Trial registration details Japan Registry of Clinical Trials jRCTs032230339.