Study on the Effect of 40 Hz Non-Invasive Light Therapy System
ConditionAlzheimer's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorZealand University Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Light Therapy System (LTS): Active Setting
- Light Therapy System (LTS): Sham Setting
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Zealand University Hospital
Lead sponsor
OptoCeutics
Collaborator
University of Copenhagen
Collaborator
Technical University of Denmark
Collaborator
Göteborg University
Collaborator
Source ClinicalTrials.gov