An Exploratory Study of Near-infrared Light Therapy for Mild to Moderate Alzheimer's Disease

This is an exploratory clinical study to evaluate the efficacy and safety of near-infrared light therapeutics in the treatment of mild to moderate Alzheimer's disease.

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Device: Near infrared light therapy

Detailed Description

This experiment adopts a single-center, single-arm research design. All the patients who signed the informed consent were screened, and qualified subjects could only be enrolled to receive NIR therapy. This study plans to enroll 40 patients, all of whom meet the enrollment conditions will receive NIR therapy, and the treatment is arranged to be once a day, once a 30min NIR therapy, 6 times a week. The treatment lasted for 96 weeks, and follow-up and assessment were performed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, 96 weeks. During the first week of treatment, caregivers will be trained in the use of the NIR device, and after the training is complete, researchers will also provide remote guidance, making visits as needed. Changes in the 96-week ADAS-cog score from baseline were used as the primary endpoint to verify the efficacy and safety of the NIR device.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Yi Tang, MD, PhD; Phone Number: 0086+1083199456; Email: tangyi@xwhosp.org

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Xuanwu Hospital, Capital Medical University
      • Contact: Yi Tang, MD, PhD; Phone Number: 0086+1083199456; Email: tangyixw@vip.163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 50 - 90 years old, no gender limitation;
• Meeting the National Institute on Aging and Alzheimer's Association (2011 NIA-AA) is likely the core clinical diagnostic criteria for Alzheimer's disease;
• The MMSE score is ≥ 12 and ≤ 26;
• The subjects should have primary school education or above and be able to complete the cognitive ability measurement and other tests stipulated in the protocol;
• If taking cognitive-improving medications, the dose must be stable for at least 12 weeks prior to enrollment (stable for at least 4 weeks with psychotropic medications);
• Participants themselves or their guardians voluntarily participate and sign the informed consent.

Exclusion Criteria:

• Any cognitive impairment or dementia not caused by Alzheimer's disease, or co-existing with a serious mental illness (schizophrenia, bipolar disorder, major depression, etc.);
• Currently taking anticoagulant drugs;
• A history of seizures or hemorrhagic stroke within 12 months;
• Allergic to sunlight or visible light or high sensitivity to head and neck skin;
• Severe head trauma or implants (bone nails, bone plates, excision, etc.);
• Malignant tumors;
• Any other medical condition that is not stabilized and adequately controlled (such as serious heart, respiratory, gastrointestinal, or kidney disease), or that the investigator believes may affect patient safety or interfere with the evaluation of the test;
• Persons addicted to alcohol or drugs;
• Women who are pregnant, nursing or planning a pregnancy;
• Participated in other clinical studies within 1 month before participating in this trial;
• Other conditions deemed unsuitable for clinical trial participation by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Once a day, once 30 minutes of near-infrared light treatment, 6 times a week for 96 weeks	Device: Near infrared light therapy; Once a day, once 30 minutes of near-infrared light treatment, 6 times a week for 96 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)	change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)	baseline, 96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADAS-Cog	change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)	baseline,12 weeks,24 weeks,36 weeks,48 weeks, 60 weeks, 72 weeks, 84 weeks
Mini Mental state Examination (MMSE)	change from baseline on the Mini Mental state Examination (MMSE) score	baseline,12 weeks,24 weeks,36 weeks,48 weeks, 60 weeks, 72 weeks, 84 weeks, 96 weeks
Quantification of T-cell Subpopulation Proportions in Cerebrospinal Fluid (CSF) via Single-Cell RNA Sequencing	To determine the proportional abundance of T-cell subsets (e.g., CD4+, CD8+, regulatory T cells) within the cerebrospinal fluid (CSF) of patients using single-cell RNA sequencing (scRNA-seq).	baseline, 12 weeks
Comprehensive Profiling of Glycolytic and Lipid Metabolic Substrates in Cerebrospinal Fluid (CSF) via Metabolomics	To quantify the concentrations of key metabolites involved in glycolysis (e.g., glucose, lactate, pyruvate) and lipid metabolism (e.g., free fatty acids, acylcarnitines, phospholipids) in cerebrospinal fluid (CSF) using liquid chromatography-tandem mass spectrometry (LC-MS/MS)-based metabolomics.	baseline, 12 weeks
Quantification of Alzheimer's Disease (AD)-Associated Pathogenic Proteins in Cerebrospinal Fluid (CSF) via Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)	To measure the concentration of AD-related neurotoxic proteins (e.g., amyloid-beta 42 [Aβ42], total tau, phosphorylated tau [p-tau181/217], neurofilament light chain [NfL]) in cerebrospinal fluid (CSF) using high-sensitivity liquid chromatography-tandem mass spectrometry (LC-MS/MS).	baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: February 16, 2025
• First Posted (Actual): February 20, 2025

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: 2024443

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