Efficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease

Study Overview
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Brief Summary
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To explore the efficacy and safety of near infrared light therapy for Alzheimer's disease. Each subject will be numbered and their medical records will be established. The subjects will be randomly assigned to the treatment group or the control group for 30 minutes/day (5-6 days a week) for 4 months while the treatment group is active settings and the control group is sham settings.Follow-up visits will be conducted at 2 months, 4 months and 2 months after treatment. At each follow-up, scale assessment, blood, MRI, and EEG were observed

Official Title
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Efficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease

Conditions
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Mild to Moderate Alzheimer's Disease

Intervention / Treatment
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* Device: treatment group-Device: NirsCure - Active NirsCure - Active settings
* Device: placebo group-Device: NirsCure - Sham NirsCure - Sham settings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age of registration is 50-85 years old, male or female. The MMSE score < 26 points can be used to complete the scale assessment. Patients who are not on medication and who are taking psychotropic or cognitive-improving drugs must have a stable dose for at least 12 weeks before the trial and remain the same for the duration of treatment. Agree to participate in the clinical trial, willing to maintain the original treatment plan during the trial, and have signed the informed consent Exclusion Criteria: MRI showed evidence of abnormalities other than Alzheimer's disease, such as cerebral infarction at key sites and severe leukodystrophy (Fezakas>Level 3). There are contraindications to MRI scanning, such as metal implants, claustrophobia, etc. A history of stroke or seizures. Photosensitive to sunlight or visible light, eczema or increased sensitivity of the skin at the treatment site. Severe vision or hearing impairment. Alcohol dependence, drug or other drug addiction or addiction tendency. During the study , subjects were pregnant, breastfeeding, or planning to pregnancy. He/She is currently participating in another study related to the treatment of AD. Researchers think that participants could not be included.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The subjects will be randomly assigned to the treatment group or the control group for 30 minutes/day (5-6 days a week) for 4 months while the treatment group is active settings and the control group is sham settings.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment group<br>active setting | Device: treatment group-Device: NirsCure - Active NirsCure - Active settings<br>* Treatment was performed once a day,5-6 times a week for 16 weeks.<br>|
| Placebo Comparator: Control group<br>sham setting | Device: placebo group-Device: NirsCure - Sham NirsCure - Sham settings<br>* Treatment was performed once a day,5-6 times a week for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in ADAS-cog | Alzheimer's Disease Assessment Scale - Cognitive section ,ADAS-Cog；The higher the score, the worse. | 8 weeks, 16 weeks and 24 weeks | 
| Change from baseline in MMSE | (Mini-Mental State Examination, MMSE ;The higher the score, the better. | 8 weeks, 16 weeks and 24 weeks | 
| Change from baseline in ALFF | The amplitudeof low-frequency fluctuations, ALFF;The increase of ALFF indicates that neuronal excitability and metabolism are enhanced, while the decrease of ALFF indicates that neuronal spontaneous activity is inhibited. | 8 weeks, 16 weeks and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in MOCA | Montreal Cognitive Assessment, MoCA；The higher the score, the better. | 8 weeks, 16 weeks and 24 weeks | 
| Change from baseline in ADCS-CGIC | Alzheimer's Disease Cooperative study-clinical global impression of change scale，ADCS-CGIC | 8 weeks, 16 weeks and 24 weeks | 
| Change from baseline in ADCS-ADL | Alzheimer's Disease Cooperative study-Activities of Daily Living Scale，ADCS-ADL;The higher the score, the better. | 8 weeks, 16 weeks and 24 weeks | 
| Change from baseline in NPI | Neuropaychiatic Inventory，NPI；The higher the score, the worse. | 8 weeks, 16 weeks and 24 weeks | 
| Change from baseline in HAMD | Hamilton depression scale,HAMD; The higher the score, the worse. | 8 weeks, 16 weeks and 24 weeks | 
| Aβ amyloid and tau levels | Plasma Aβ and Tau proteins are thought to be related to the pathogenesis of AD; The lower the protein level, the better. | 8 weeks, 16 weeks and 24 weeks | 
| MRI | Magnet Resonance Imaging,MRI; The brain volume, hippocampus volume, links between brain regions will be observed. | 8 weeks, 16 weeks and 24 weeks |