Study on the Effect of 40 Hz Non-Invasive Light Therapy System
Recruiting · NCT05260177 · Interventional (participants receive a specific treatment) · Lead sponsor: Zealand University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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
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 visual system, prefrontal cortex, or hippocampus, or relevant lesions detected by pre-trial imaging.
- 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.
- Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the PI)
Where it is running
1 location listed.
- Zealand University Hospital - Roskilde, Denmark