NCT05260177 Study on the Effect of 40 Hz Non-Invasive Light Therapy System
| NCT ID | NCT05260177 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zealand University Hospital |
| Condition | Alzheimer's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2022-09-20 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2022-09-20 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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)
Contact & Investigator
Maibritt Horning, MSc
STUDY CHAIR
Zealand University Hospital, Department of Neurology
Frequently Asked Questions
Who can join the NCT05260177 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Alzheimer's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05260177 currently recruiting?
Yes, NCT05260177 is actively recruiting participants. Contact the research team at phh@regionsjaelland.dk for enrollment information.
Where is the NCT05260177 trial being conducted?
This trial is being conducted at Roskilde, Denmark.
Who is sponsoring the NCT05260177 clinical trial?
NCT05260177 is sponsored by Zealand University Hospital. The principal investigator is Maibritt Horning, MSc at Zealand University Hospital, Department of Neurology. The trial plans to enroll 62 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.