Suspended

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

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What is being tested

treatment group-Device: NirsCure - Active NirsCure - Active settings

+ placebo group-Device: NirsCure - Sham NirsCure - Sham settings

Device
Who is being recruted

Over 50 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2023
See protocol details

Summary

Principal SponsorDanyang Huichuang Medical Equipment Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2023

Actual date on which the first participant was enrolled.

This study is investigating the use of near infrared light therapy as a potential treatment for Alzheimer's disease. Alzheimer's is a progressive brain disorder affecting memory and cognitive functions, making it challenging for those diagnosed and their families. The study aims to determine if this type of light therapy can improve symptoms or slow down the progression of the disease while also ensuring it is safe for patients. Finding effective treatments is crucial as current options are limited, and Alzheimer's significantly impacts quality of life. Participants in the study are divided into two groups: a treatment group receiving active near infrared light therapy and a control group receiving a sham or inactive treatment. The therapy is administered for 30 minutes daily, 5 to 6 days a week over a four-month period. Researchers evaluate the effectiveness and safety by conducting follow-up visits at intervals of 2 months and 4 months during treatment, and then again 2 months after the treatment ends. During these visits, participants undergo various assessments, including scale evaluations, blood tests, MRI scans, and EEG tests to monitor changes in their condition and any potential side effects.

Official TitleEfficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease
NCT06008639
Principal SponsorDanyang Huichuang Medical Equipment Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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

9 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
active setting

Group II

Placebo
sham setting

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids

Beijing, ChinaOpen Rehabilitation hospital affiliated National Research Center for Rehabilitation Technical Aids in Google Maps
Suspended

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China
Suspended2 Study Centers