NCT05260177Recruiting
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
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 26 Jan 2022
- Start date
- 20 Sept 2022
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- Zealand University Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT05260177
What you commit to
- Study type: Interventional
- Planned participants: 62
- From 20 Sept 2022 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of significant diseases related to the visual system or the brain.
- Medication: Use of any antiepileptic drugs, neuromodulating drugs or high dose of sedatives will be excluded.
- Prior history of substance abuse within the past 2 years.
Other illness
- Profound visual impairment (visual acuity \> 0.5) provided correction with spectacles, if needed
- Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the PI)
Other
- Significant abnormalities related to important parts of the brain, e.g., the visual system, prefrontal cortex, or hippocampus, or relevant lesions detected by pre-trial imaging.
Who the study is looking for
- Adult competent person, able to understand the nature of the study and give written informed consent.
- Diagnosed with probable mild to moderate AD based on NIA-AA diagnostic criteria or in a prodromal stage of AD with at least one positive biomarker of AD.
- Age \> 40 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 for neuropsychological testing.
- Participants must have a designated caregiver, who is available to the participant and can provide the necessary assistance with using the LTS device and the Actigraph wearable at home and assist with clinical visits and other practical issues
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zealand University Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.