Neuro RX Gamma - Pivotal Phase
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alzheimer Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03484143
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Corinne Fischer, MD Unity Health Toronto