AbstractBackgroundThe current evidence supporting nonpharmacologic treatment of dementia has focused mainly on environmental or interactive interventions, e.g., music, sensory stimulation, simulated presence, and validation therapies. Exercise and light therapy improved/maintained activities of daily living, while cognitive stimulation, exercise and reminiscence improved cognition. The strongest evidence for reducing emotional disorders so far has employed music, psychological interventions and reminiscence. PubMed lists 918 citations related to non‐pharmacological treatments for dementia with music therapy and behavioral management techniques being the most efficacious showing modest improvements at best. Non‐pharmacologic treatment interventions directed at reversing both cognitive and behavioral symptom of dementia are small, few in number and with wide variation in defining outcome measures, and little comparative data across approaches to guide further research efforts or systematic clinical applicability. Photobiomodulation using brief, daily, pulsed LED‐driven transcranial infrared light stimulation, has been shown to markedly alter both cognitive and behavioral symptoms in people with mild to moderate dementia. Improved functioning has been documented by both standard neuropsychological testing and noninvasive Quantitative electroencephalographic (QEEG) measures of functional connectivity. This presentation describes a multi‐site, randomized, placebo controlled, at‐home, self‐administered treatment protocol employing pulsed transcranial and intraocular 1068nm near‐infrared light to achieve reversal of cognitive decline, and improve dementia patient’s physical and interpersonal behavior. Study subjects (n=100) were evaluated at two locations at baseline, midpoint (30 days) and termination (60 days) using both Quantitative EEG and ADAS‐Cog and caregiver evaluation of subject’s change in ADLs. This trial was a replication of an earlier pilot trial and a recent safety/feasibility trial with no adverse events reported in any study. MMSE improved 21.0%, 4.8 points in the active treatment group and 1.6 points in the placebo group. Sleep duration increased in the active treatment group by an hour after 8 days of treatment and caregivers noted improved mood, energy, and positive engagement in daily activities. None of these functional changes were noted in the placebo arm subjects. Active group’s clock drawing improved 20% and no change in the control group. Logical memory recall improved 3.3 points (p< .03) and time to completion of Trails A&B decreased 23.7% (p<.03).
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