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

NCT ID: NCT06836180

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2030-12-31

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.

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Near infrared light therapy

Intervention Type: DEVICE

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

Interventions

Near infrared light therapy

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yi Tang, MD, PhD

Role: CONTACT

tangyi@xwhosp.org

0086+1083199456

Facility Contacts

Yi Tang, MD, PhD

Role: primary

tangyixw@vip.163.com

0086+1083199456

Other Identifiers

2024443

Identifier Type: -

Identifier Source: org_study_id