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Neuro RX Gamma - Pivotal Phase

NCT03484143 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2023-01-25

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

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

Sponsors & Collaborators

  • Vielight Inc.

    lead INDUSTRY

Principal Investigators

  • Corinne Fischer, MD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03484143 on ClinicalTrials.gov