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Procedure

Neuro RX Gamma for Mild Cognitive Impairment

N/A
Recruiting
Led By Corinne Fischer, MD
Research Sponsored by Unity Health Toronto
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 and 6 weeks post randomization

Summary

This trial will study the effects of transcranial near infrared light on the cognitive changes and neural correlates associated with Alzheimer's disease.

Who is the study for?
This trial is for people over 50 with mild cognitive impairment due to Alzheimer's, who function normally in daily life and have a specific score range on the MoCA test. They must be stable on certain dementia medications if used, and have a caregiver to help with home treatments. Excluded are those with substance abuse issues, unstable illnesses, non-English speakers without grade eight education level, or involvement in other drug trials.
What is being tested?
The Neuro RX Gamma device uses near-infrared light therapy thought to improve brain function by enhancing mitochondrial activity. Participants will use this device at home for six weeks. The study includes clinical assessments and MRI scans before and after treatment to evaluate changes in cognition and brain activity.
What are the potential side effects?
Potential side effects aren't specified but may include discomfort from wearing the device or sitting still during sessions, skin sensitivity where the light is applied, or anxiety related to using the equipment at home.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 weeks post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 weeks post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes from pre- to post-treatment on executive functioning assessed by Trail Making Test (TMT)-B/A and Stroop Color and Word Test (SCWT)
Changes from pre- to post-treatment on mental status and cognitive function assessed by Mini-Mental State Examination (MMSE)
Changes from pre- to post-treatment on processing speed assessed by Trail Making Test (TMT)-part A
+2 more
Secondary study objectives
Changes from pre- to post-treatment on Neuropsychiatric symptoms (NPS) using MBI-C (Mild Behavioral Impairment Checklist)
Changes from pre- to post-treatment on Pittsburgh sleep quality index
Changes from pre- to post-treatment on Quality of life using QOL-AD
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active Neuro Rx DeviceActive Control1 Intervention
The active device will deliver light for the 20 minutes session duration.
Group II: Sham Neuro Rx DevicePlacebo Group1 Intervention
The Sham device is indistinguishable from the active device. The sham device will not deliver light for the 20 minutes session duration.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
556 Previous Clinical Trials
454,386 Total Patients Enrolled
Corinne Fischer, MDPrincipal InvestigatorUnity Health Toronto
2 Previous Clinical Trials
258 Total Patients Enrolled

Media Library

Neuro RX Gamma (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05563298 — N/A
Mild Cognitive Impairment Research Study Groups: Active Neuro Rx Device, Sham Neuro Rx Device
Mild Cognitive Impairment Clinical Trial 2023: Neuro RX Gamma Highlights & Side Effects. Trial Name: NCT05563298 — N/A
Neuro RX Gamma (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05563298 — N/A
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05563298 — N/A
~3 spots leftby Mar 2025
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