Effect of 40 Hz Light Therapy on Alzheimer's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.