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Device
Active Neuro RX Gamma device for Alzheimer's Disease
N/A
Waitlist Available
Led By Corinne Fischer, MD
Research Sponsored by Vielight Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24 compared to 24 weeks prior to study intervention
Awards & highlights
Summary
This trial will test whether the Neuro RX Gamma device is effective in improving cognitive functioning and quality of life in patients with moderate to severe Alzheimer's Disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 24 compared to 24 weeks prior to study intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24 compared to 24 weeks prior to study intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Alzheimer's Disease
Change in European Quality of Life Scale (EQ-5 dimensions [5D], proxy version)
Change in Neuropsychiatric Inventory Questionnaire (NPI) - including Caregiver Distress ratings
+2 moreOther outcome measures
Device related Adverse Events
Rates of device/treatment anxiety
Rates of epistaxis in aspirin/anti-coagulant users
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Neuro RX Gamma deviceActive Control1 Intervention
Neuro RX Gamma device delivers low-energy near-infrared light, through 5 diodes, to the brain transcranially and intranasally
Group II: Sham Neuro RX Gamma devicePlacebo Group1 Intervention
Sham Neuro RX Gamma device is identical in appearance and sound as the active Neuro RX Gamma device but does not emit low-energy near infrared light
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Who is running the clinical trial?
Vielight Inc.Lead Sponsor
4 Previous Clinical Trials
411 Total Patients Enrolled
Corinne Fischer, MDPrincipal InvestigatorUnity Health Toronto
2 Previous Clinical Trials
50 Total Patients Enrolled
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