CLINICAL RESEARCH STUDY

In the early stages of Alzheimer's disease, it's common for individuals to experience mild cognitive impairment (MCI) or mild dementia. During this phase, while there may be memory lapses or other cognitive challenges, most individuals can still manage most daily tasks independently. ¹Often, the individual might feel they're becoming forgetful, and their family or close friends might observe behavioral changes. ² A doctor can pinpoint these symptoms using various diagnostic tools and questionnaires. 3Some typical difficulties faced during mild cognitive impairment and mild dementia include²:Struggling to recall the right word or name.Forgetting recent readingsNot remembering names of new acquaintancesEncountering challenges while handling specific tasks at work or in social situationsMisplacing or losing valuable itemsFacing increased troubles in organizing and planning.

References:
1. Mild cognitive impairment. Alzheimer’s Association. Accessed August 16, 2023. https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment
2. Stages of Alzheimer’s/Alzheimer’s and dementia. Alzheimer’s Association. Accessed August 16, 2023. https://www.alz.org/alzheimers-dementia/stages
3. How is Alzheimer's disease diagnosed? U.S. Department of Health and Human Services. National Institute on Aging. https://www.nia.nih.gov/health/how-alzheimers-disease-diagnosed

The Neuronic Study is evaluating the effects of the new Neuradiant Pro device on individuals with mild cognitive impairment or mild dementia due to Alzheimer’s disease.

The study lasts between 16 to 18 weeks. We will deliver the Neuradiant Pro device to your home and provide instructions for use. The study can conveniently be done at home with periodic online check-ins. You will only be required to physically attend to a nearby clinic twice to obtain an electroencephalogram (EEG) test.

Category 1 (1040 nm vs 1070 nm PBM) of the study will start in October 2023.
Category 2 (Active 1070 PBM vs Sham control) will start in Quarter 1 2024.

An electroencephalogram (EEG) test is a simple and painless procedure used to measure the electrical activity in your brain. During the test, small sensors are attached to your scalp using a special gel or adhesive. These sensors pick up the brain's electrical signals and display them on a computer. You'll typically sit during the procedure, and you might be asked to do certain tasks or relax. It's a safe way to understand how your brain is working.

Transcranial photobiomodulation (tPBM) is a non-invasive technique that uses light to stimulate brain cells, aiming to improve neural function and health. Generally, photobiomodulation devices are considered a non-significant risk (NSR).

You could experience side effects associated with the active tPBM device or the placebo. Your symptoms may not improve or may get worse during the clinical research study. The study team will discuss all the possible risks in detail with you.

Some participants might experience signs of overstimulation like dizziness, headaches, or fatigue. These symptoms are generally mild and resolve within hours. It's important to stay hydrated and have eaten prior to using the device.

Continue taking your medications as prescribed. However, always communicate with your physician throughout the study period.

Your privacy is paramount. All personal and medical data is kept confidential and will be anonymized. The data will only be accessible to authorized personnel, as outlined in the informed consent process.

Neuronic Devices Operations GmBH is sponsoring the study.

All study-related procedures and the Neuradiant Pro device will be provided at no cost.

Your participation is entirely voluntary, and you can withdraw at any time. If you choose to leave the study before its completion, the device must be returned to Neuronic within 2 weeks.

Yes! As a token of our gratitude, you will receive a $75 gift card from Neuronic upon successful completion of the study.