Study on the Effect of 40 Hz Non-Invasive Light Therapy System

Study purpose

The ALZLIGHT STAGE III Study is a continuation of the ALZLIGHT Pilot - Study on Safety, Feasibility and Neural Activation of Non-Invasive Light Therapy System. As with the first two stages, this study will examine whether entrainment of 40 Hz neural oscillation by novel 40 Hz Invisible Spectral Flicker is a potential therapy for Alzheimer's Disease. In order to examine this, 62 patients with mild to moderate Alzheimer's Disease will be recruited. The patients will be exposed to the Non-Invasive Light Therapy System for 1 hour a day for 6 months. The effect will be measured by a combination of electroencephalography, cognitive testing, functional magnetic resonance imaging, magnetic resonance spectroscopy and actigraphy.

Detailed description

Recent studies in mouse models of Alzhimer's Disease (AD) have shown that exposure to 40 Hz stroboscopic light therapy for one hour a day, resulted in slowing disease progression and lead to multiple neuroprotective effects such as cognition and memory recovery, and even scavenged both tau and Aβ protein species. Hence, the 40 Hz stroboscopic light therapy has a considerable potential for treatment of humans. This study will utilize a novel way of masked light by alternating the spectral composition of a white light, rendering the flicker invisible to the conscience perception, while still entraining 40 Hz oscillations in the brain. In the study, 62 patients with probable mild to moderate AD will be exposed to either invisible spectral flickering light through the Light Therapy System (LTS) (active setting) or continuous non-flickering white light (sham setting) for 1 hour each day. The sham setting is a high quality sham intervention as subjects will be blinded to the setting, both appear as white light. The study participation will last 12 months for each participant and consist of 3 periods: An enrollment period, a randomized intervention period of 6 months, and 6 months of active intervention. In order to test whether the LTS intervention is a potential treatment for AD, cognition will be measured by neuropsychological tests at baseline and at follow-ups. To get a better understanding of the potential effects, markers of efficacy based on MRI, MRS, EEG and blood samples will be tested. The results from this study will increase the understanding of the impact of gamma oscillations in the human brain, and how it can be utilized as a novel and important tool for the treatment of neurodegenerative diseases.

Treatment groups

Active EXPERIMENTAL — Exposure to LTS device set to 40 Hz invisible spectral flicker for 1 hour a day for consecutive days Interventions: Device: Light Therapy System (LTS): Active Setting

Sham SHAM_COMPARATOR — Exposure to LTS device set to continuous color matched white light for 1 hour a day for consecutive days Interventions: Device: Light Therapy System (LTS): Sham Setting

Primary outcomes

Gamma oscillations assessment — Determine the total gamma power at 40 Hz, with no concomitant LTS device stimulation, assess changes in the gamma power at 40 Hz. Time frame: Change from Baseline to 6 months

Induction of 40 Hz Gamma oscillations — Estimate the change in electrical field patterns by EEG SSVEP, assess the difference between placebo and treatment for power spectral density signal to noise ratio at baseline measured by EEG SSVEP Time frame: Change from Baseline to 6 months

Study design

Allocation: RANDOMIZED · Intervention model: PARALLEL · Purpose: TREATMENT · Enrollment: 62

Source: ClinicalTrials.gov · Preserved current registry observation 72540