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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Light Therapy System (LTS): Active Setting
DeviceExposure for 1 hour á day for consecutive days
Light Therapy System (LTS): Sham Setting
DeviceExposure for 1 hour á day for consecutive days
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: ActiveExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gamma oscillations assessment
Determine the total gamma power at 40 Hz, with no concomitant LTS device stimulation, assess changes in the gamma power at 40 Hz.
Time frame
Change from Baseline to 6 months2
Induction of 40 Hz Gamma oscillations
Estimate the change in electrical field patterns by EEG SSVEP, assess the difference between placebo and treatment for power spectral density signal to noise ratio at baseline measured by EEG SSVEP
Time frame
Change from Baseline to 6 monthsSecondary outcomes
1
Cognition and memory assessment
Assess changes in cognition measured by the Alzheimer's Disease Assessment Scale -Cognitive Subscale plus Executive Functioning and Functional Ability (ADAS Cog plus EF \& FA). The score ranges from 0 to 135. A higher score reflects greater cognitive impairment.
Time frame
Change from Baseline to 6 months and 12 months2
Cognition and memory assessment
Assess changes in cognition measured by the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL). The score ranges from 0 to 78. A higher score reflects a better outcome.
Time frame
Change from Baseline to 6 months and 12 months3
Cognition and memory assessment
Assess changes in cognition measured by the Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30. A higher score reflects a better outcome.
Time frame
Change from Baseline to 6 months and 12 months4
Connectivity measures
rs-fMRI Connectivity: Estimate the temporal correlation between cortical regions, assess changes in correlation between cortical regions from baseline to 6 months
Time frame
Change from Baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zealand University Hospital
Lead sponsor
OptoCeutics
Collaborator
University of Copenhagen
Collaborator
Technical University of Denmark
Collaborator
Göteborg University
Collaborator
Source ClinicalTrials.gov