Status:
RECRUITING
Study on the Effect of 40 Hz Non-Invasive Light Therapy System
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
OptoCeutics
University of Copenhagen
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Recent studies in mouse models of Alzhimer's Disease (AD) have shown that exposure to 40 Hz stroboscopic light therapy for one hour a day, resulted in slowing disease progression and lead to multiple ...
Eligibility Criteria
Inclusion
- 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.
- Age \> 55 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
- 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)
Key Trial Info
Start Date :
September 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05260177
Start Date
September 20 2022
End Date
December 1 2026
Last Update
January 24 2024
Active Locations (1)
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1
Zealand University Hospital
Roskilde, Denmark, 4000