Actively Recruiting
Study on the Effect of 40 Hz Non-Invasive Light Therapy System
Led by Zealand University Hospital · Updated on 2026-05-07
62
Participants Needed
1
Research Sites
323 weeks
Total Duration
On this page
Sponsors
Z
Zealand University Hospital
Lead Sponsor
O
OptoCeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on the Effect of 40 Hz Non-Invasive Light Therapy System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult competent person able to understand the study and give written informed consent
- Diagnosed with probable mild to moderate Alzheimer's Disease or prodromal stage with at least one positive biomarker
- Age over 40 years; females must be post-menopausal
- Fluent in Danish
- More than 8 years of normal school education
- Pass a color-blindness test (Ishihara color test)
- Have necessary visual, auditory, and language skills for neuropsychological testing
- Have a designated caregiver available to assist with using the light therapy device, the Actigraph wearable, clinical visits, and other practical matters
You will not qualify if you...
- Profound visual impairment (visual acuity worse than 0.5) even with correction
- Significant abnormalities in brain areas such as visual system, prefrontal cortex, or hippocampus detected by imaging
- Prior history of significant diseases related to the visual system or brain
- Use of any antiepileptic drugs, neuromodulating drugs, or high doses of sedatives
- History of substance abuse within the past 2 years
- Any significant systemic illness or unstable medical condition that may make it hard to follow the study protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zealand University Hospital
Roskilde, Denmark, 4000
Actively Recruiting
Research Team
P
Peter Høgh, MD, Phd
CONTACT
M
Maibritt Horning, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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