RecruitingNot ApplicableNCT05260177

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

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

Sponsor

Zealand University Hospital

Enrollment

62 participants

Start Date

Sep 20, 2022

Study Type

INTERVENTIONAL

Conditions

Alzheimer s Disease

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a light and sound therapy device that delivers flashing lights and sounds at a specific frequency (40 Hz) to see if it can slow the progression of mild-to-moderate Alzheimer's disease. The device is used at home under caregiver supervision. **You may be eligible if...** - You are over 55 years old and have been diagnosed with probable mild to moderate Alzheimer's disease - You are female and have gone through menopause - You speak Danish fluently and have had at least 8 years of schooling - You pass a color-blindness test - You have a caregiver who can help you use the device at home and accompany you to clinic visits **You may NOT be eligible if...** - You have significant vision or hearing impairment - You have a history of epilepsy or seizures - You take certain medications that could interfere with the treatment - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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