Efficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease
treatment group-Device: NirsCure - Active NirsCure - Active settings
+ placebo group-Device: NirsCure - Sham NirsCure - Sham settings
Treatment Study
Summary
Study start date: March 1, 2023
Actual date on which the first participant was enrolled.This study is investigating the use of near infrared light therapy as a potential treatment for Alzheimer's disease. Alzheimer's is a progressive brain disorder affecting memory and cognitive functions, making it challenging for those diagnosed and their families. The study aims to determine if this type of light therapy can improve symptoms or slow down the progression of the disease while also ensuring it is safe for patients. Finding effective treatments is crucial as current options are limited, and Alzheimer's significantly impacts quality of life. Participants in the study are divided into two groups: a treatment group receiving active near infrared light therapy and a control group receiving a sham or inactive treatment. The therapy is administered for 30 minutes daily, 5 to 6 days a week over a four-month period. Researchers evaluate the effectiveness and safety by conducting follow-up visits at intervals of 2 months and 4 months during treatment, and then again 2 months after the treatment ends. During these visits, participants undergo various assessments, including scale evaluations, blood tests, MRI scans, and EEG tests to monitor changes in their condition and any potential side effects.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids
Beijing, ChinaOpen Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids in Google MapsThe First Affiliated Hospital of Chongqing Medical University
Chongqing, China