Your session is about to expire
← Back to Search
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 weeks post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 weeks post randomization
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 moreSecondary 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 moreTrial 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
562 Previous Clinical Trials
453,868 Total Patients Enrolled
Corinne Fischer, MDPrincipal InvestigatorUnity Health Toronto
2 Previous Clinical Trials
258 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of stroke, seizures, MS, light sensitivity, or Lyme disease.I have a brain condition affecting my thinking, but it's not Alzheimer's.I have no issues with walking, seeing, or hearing that would affect my participation.I have had frequent nosebleeds in the last 6 months or am on strong blood thinners.I do not have any uncontrolled illnesses like diabetes or high blood pressure.I have a history of severe agitation, aggression, or seizures.I am currently receiving light therapy treatment.I have been on a stable dose of cholinesterase inhibitors or memantine for the last 3 months.I am 50 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Active Neuro Rx Device
- Group 2: Sham Neuro Rx Device
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05563298 — N/A