Neuro RX Gamma - Pivotal Phase

A potential participant will undergo pre-screening and screening assessments to assess eligibility for the study. Eligible participants will undergo a baseline visit in which they will be randomized to either active or sham Neuro RX Gamma device. The Vielight Neuro RX Gamma is a non-invasive device that administers low-energy near-infrared LED (light emitting diode) light to the brain transcranially and intranasally. There are two treatment phases in the trial, each with a duration of 12 weeks. The patient along with the caregiver will perform home (or living facility) - based treatments with the device and document the sessions in a patient diary. The device will be applied to the patient participant by a dedicated caregiver for a 20 minute daily session, 6 days a week for a total of 12 weeks. The study participant and caregiver will be required to return to the clinic for follow-up assessments at 12 and 24 weeks post randomization, between treatment phases. 228 patients will be enrolled across 12 sites in Canada and the United States.