TD‐P‐010: Significant Improvement in Memory and Quality of Life After Transcranial and Intranasal Photobiomodulation: a Randomized, Controlled, Single‐Blind Pilot Study with Dementia

Previous mouse-model investigations of photobiomodulation (PBM) for Alzheimer’s disease (AD) have demonstrated biomarker reductions, improved behavior. This is the first human study to investigate the effects of PBM on memory and quality of life (QoL) issues associated with dementia/AD. This was a randomized, single-blind, controlled study of 12 weeks of PBM with a 4-week no-treatment follow-up in 19 participants with impaired memory who responded to a local newspaper advertisement. In-clinic treatment with an 810 nm, light-emitting diode (LED) combined transcranial and intranasal PBM device (total power 515 mW) or sham equivalent was delivered 2x/week for 2 weeks, then weekly for 10 weeks. On non-clinic days during the treatment phase, participants self-administered treatment at home with an 810 nm intranasal device (13 mW) or sham equivalent. Memory and cognition were assessed using MMSE and ADAS-cog at Baseline, at Week 12; and follow-up after 4 weeks of no treatment. Mean(SD) baseline MMSE and ADAS-cog scores were 18.4(9.37) and 32.1(21.41) in the active group, (n=13, 10M, 3F) compared with 25.8(4.36) and 14.8(7.91) in the sham group (n=6, 5M, 1F). Since these were significantly different (p<0.1 for both), data were analyzed by baseline MMSE. In the baseline MMSE 0-24 subgroup, Week 12 scores were significantly improved for the 8 participants on active treatment: MMSE increased 2.00 points (p=0.03, 2-tailed) and ADAS-cog decreased 5.00 points (p=0.03). The only sham participant in this subgroup dropped out before post-baseline assessment. Slight declines in performance were noted at follow-up after 4 weeks of no treatment. In the baseline MMSE 25-30 subgroup, mean changes at Week 12 in MMSE and ADAS-cog were 1.80 and -2.27 in the active group (n=5), versus 1.50 and -3.67 in the sham group (n=5). None of the within-group or between-group comparisons were statistically significant for this milder group. Qualitative feedback from participants and caregivers in the active group reported better sleep, fewer angry outbursts and decreased anxiety, and wandering. No adverse events related to treatment were reported. The large significant improvements in cognitive functioning, QoL and lack of adverse events suggest that PBM therapy may show promise in treatment of individuals experiencing dementia/AD.