Effect of 40 Hz Light Therapy on Alzheimer's Disease
ALZLIGHT Stage III - Study on the Effect of 40 Hz Non-Invasive Light Therapy System
This study is testing whether a special light therapy can help improve thinking and memory in people with mild to moderate Alzheimer's Disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Roskilde) |
| Trial ID | NCT05260177 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a non-invasive light therapy system that uses 40 Hz invisible spectral flicker on patients with mild to moderate Alzheimer's Disease. A total of 62 participants will receive either the active light therapy or a sham treatment for one hour daily over six months. The study aims to assess cognitive improvements and neuroprotective effects through various measurements, including EEG, MRI, and neuropsychological tests. The innovative approach of using invisible flicker aims to enhance patient comfort while potentially providing therapeutic benefits.
Who should consider this trial
Good fit: Ideal candidates are adults over 55 years old diagnosed with mild to moderate Alzheimer's Disease who can provide informed consent and have a designated caregiver.
Not a fit: Patients with profound visual impairments or significant brain abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could slow the progression of Alzheimer's Disease and improve cognitive function in affected patients.
How similar studies have performed: Previous studies in animal models have shown promising results with similar light therapy approaches, suggesting potential efficacy in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Roskilde
- Zealand University Hospital — Roskilde, Denmark (Recruiting)
Study contacts
- Principal investigator: Peter Høgh, MD, Phd — Zealand Univeristy Hospital, Department of Neurology
- Study coordinator: Peter Høgh, MD, Phd
- Email: phh@regionsjaelland.dk
- Phone: 47322809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.