Phase 2 Study of Rhythmic Light Therapy to Improve Brain Activity and Sleep in People with Mild Cognitive Impairment or Alzheimers Disease

What this Trial Is About

This research investigates the effects of rhythmic light therapy on people with mild cognitive impairment or mild Alzheimers disease. The study evaluates how different types of light flicker, including a 40 hertz flicker and a random flicker, affect cognition and sleep disturbances. Participants are randomly assigned to one of four groups to compare the impact of circadian-effective light and placebo light combined with rhythmic or random flicker. The study is led by the Icahn School of Medicine at Mount Sinai and focuses on circadian system stimulation and cognitive outcomes. Participants will use a light device placed on a tabletop in a room where they spend at least two hours each morning. The device automatically turns on at the participants preferred wakeup time, no later than 900 am, and delivers either narrowband blue light circadian-effective or narrowband red light placebo with either a 40 Hz rhythmic flicker or a random flicker. After a baseline week, participants experience their assigned lighting condition for two hours each morning over eight weeks. This is followed by a four-week washout period before final assessments. During the study, participants undergo weekly assessments for eight weeks, measuring sleep quality, cognition, and other health markers using tools like the Montreal Cognitive Assessment and the Pittsburgh Sleep Quality Index. Additional tests include working memory tasks, implicit priming, and urine melatonin levels. Researchers track light exposure and sleep quantity with specialized devices. The total study duration includes baseline, treatment, washout, and final assessment periods, with safety and quality of life also monitored throughout.

Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients