NCT03484143

Neuro RX Gamma - Pivotal Phase

Vielight Neuro RX Gamma Photobiomodulation Device for Moderate to Severe Alzheimer's Disease

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Vielight Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The active Neuro RX Gamma device uses non-invasive near-infrared energy delivered to the brain with the intention to improve cognitive functioning and quality of life in patients with moderate to severe Alzheimer's Disease. Treatment will occur at home-based treatment sessions with the device.

Detailed description

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	Active Neuro RX Gamma device	Twenty minute treatment session, 6 days a week for 24 weeks
DEVICE	Sham Neuro RX Gamma device	Twenty minute treatment session, 6 days a week for 24 weeks

Timeline

• Start date: 2019-06-26
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2018-03-30
• Last updated: 2023-01-25

Locations

9 sites across 2 countries: United States, Canada