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

NCT06836180 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2024443
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• ADAS-Cog

  baseline,12 weeks,24 weeks,36 weeks,48 weeks, 60 weeks, 72 weeks, 84 weeks

• Mini Mental state Examination (MMSE)

  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

  baseline, 12 weeks

• Comprehensive Profiling of Glycolytic and Lipid Metabolic Substrates in Cerebrospinal Fluid (CSF) via 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)

  baseline, 12 weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

Once a day, once 30 minutes of near-infrared light treatment, 6 times a week for 96 weeks

Device: Near infrared light therapy

Interventions

Near infrared light therapy DEVICE

Once a day, once 30 minutes of near-infrared light treatment, 6 times a week for 96 weeks

Intervention group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Yi Tang, MD, PhD

CONTACT

0086+1083199456; tangyi@xwhosp.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: February 20, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 15, 2025

Record last verified: 2025-04

Locations

CN (1)