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

Phase

N/A

Condition

Memory Loss

Dementia

Alzheimer's Disease

Treatment

Light Therapy System (LTS): Sham Setting

Light Therapy System (LTS): Active Setting

Clinical Study ID

NCT05260177

ASIII

Ages > 55
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adult competent person, able to understand the nature of the study and give writteninformed consent.
Diagnosed with probable mild to moderate AD based on NIA-AA diagnostic criteria.
Age > 55 years. Females must be post-menopausal.
Fluent in Danish.
> 8 years of normal school education
Pass a color-blindness test (Ishihara color test)
Have visual and auditory capabilities, and language skills necessary forneuropsychological testing.
Participants must have a designated caregiver, who is available to the participant andcan provide the necessary assistance with using the LTS device and the Actigraphwearable at home and assist with clinical visits and other practical issues

Exclusion

Exclusion Criteria:

Profound visual impairment (visual acuity > 0.5) provided correction with spectacles,if needed
Significant abnormalities related to important parts of the brain, e.g., the visualsystem, prefrontal cortex, or hippocampus, or relevant lesions detected by pre-trialimaging.
Prior history of significant diseases related to the visual system or the brain.
Medication: Use of any antiepileptic drugs, neuromodulating drugs or high dose ofsedatives will be excluded.
Prior history of substance abuse within the past 2 years.
Any significant systemic illness or unstable medical condition, which could lead todifficulty complying with the protocol (at the discretion of the PI)

Study Design

Light Therapy System (LTS): Sham Setting

September 20, 2022

December 01, 2026

Study 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 will last 8½ months for each participant and consist of 3 periods: Enrollment period of 1 month, an intervention period of 6 months, and a 1½ month post-interventional follow-up period.

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.

Connect with a study center

Zealand University Hospital
Roskilde, 4000
Denmark
Active - Recruiting

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