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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Mild to Moderate Alzheimer's Disease
• Intervention / Treatment: Device: treatment group-Device: NirsCure - Active NirsCure - Active settings; Device: placebo group-Device: NirsCure - Sham NirsCure - Sham settings

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids
  • Sichuan
    • Chongqing, Sichuan, China, 400000
      • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Danyang Huichuang Medical Equipment Co., Ltd.
• Collaborators: First Affiliated Hospital of Chongqing Medical University; Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
• Investigators: Principal Investigator: Ping Ze Lv, Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2018YFC2001700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No