NCT07262645: Near-Infrared Light Therapy for Mild-Moderate Alzheimer's Disease

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Near-Infrared Light Therapy for Mild-Moderate Alzheimer's Disease

Trial Overview

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| Field | Value |
|-------|-------|
| NCT Number | [NCT07262645](https://clinicaltrials.gov/study/NCT07262645) |
| Status | Recruiting |
| Sponsor | Danyang Huichuang Medical Equipment Co., Ltd. |
| Phase | Phase 3 |
| Enrollment | 320 patients (estimated) |
| Start Date | December 2025 |
| Completion Date | July 2027 |

Intervention

Device: NirsCure 6000 Near-infrared light therapy
Dosage: Once daily for 30 minutes, six times per week
Control: Sham device (identical appearance, no light emission)

Study Design

...

Near-Infrared Light Therapy for Mild-Moderate Alzheimer's Disease

Trial Overview

Mermaid diagram (expand to render)

Intervention

Device: NirsCure 6000 Near-infrared light therapy
Dosage: Once daily for 30 minutes, six times per week
Control: Sham device (identical appearance, no light emission)

Study Design

Type: Interventional
Allocation: Randomized (1:1 ratio)
Model: Parallel assignment
Masking: Quadruple-blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Outcomes

Primary Outcomes

| Measure | Time Frame |
|---------|------------|
| ADAS-Cog13 (Alzheimer's Disease Assessment Scale, cognitive subscale 13) | 26 weeks |

The ADAS-Cog13 score ranges from 0 to 85, with higher scores indicating greater cognitive impairment.

Secondary Outcomes

| Measure | Time Frame |
|---------|------------|
| CDR-SB (Clinical Dementia Rating - Sum of Boxes) | 26 weeks |
| MMSE (Mini-Mental Status Examination) | 26 weeks |
| ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) | 26 weeks |
| iADRS (Integrated Alzheimer's Disease Rating Scale) | 26 weeks |

Eligibility

Inclusion Criteria

Age 50-85 years old

At least 4 years of formal education

Documented progressive memory decline for ≥12 months

Meets NIA-AA 2018 criteria for mild to moderate AD (stages 4-5)

Evidence of positive brain amyloid pathology (PET or CSF)

MMSE score 15-26 (or 12-22 for elementary school education)

CDR Global of 1 or 2, with CDR-Memory Box scores ≥ 0.5

Stable acetylcholinesterase inhibitor or memantine dose for ≥12 weeks

Has a reliable study partner

Exclusion Criteria

Non-AD dementia (vascular, Lewy body, Parkinson's, frontotemporal, etc.)

Significant brain MRI findings (>2 infarcts >2cm, Fazekas score ≥3)

TIA, stroke, or seizure within 6 months

HAMD-17 score > 10

DSM-5 psychiatric disorders

Severe cardiovascular disease

Current/prior anti-amyloid monoclonal antibody treatment

Contraindications to MRI or PET

Participating Sites

The trial is conducted at 21 sites across China:

| City | Hospital |
|------|----------|
| Beijing | Peking University First Hospital |
| Beijing | Beijing Friendship Hospital |
| Beijing | Xuanwu Hospital, Capital Medical University |
| Beijing | Peking University Third Hospital |
| Beijing | Peking Union Medical College Hospital |
| Shijiazhuang | Shijiazhuang People's Hospital |
| Baotou | Baotou Central Hospital |
| Suzhou | Second Affiliated Hospital of Soochow University |
| Suzhou | First Affiliated Hospital of Soochow University |
| Xi'an | Tangdu Hospital, Air Force Medical University |
| Xi'an | First Affiliated Hospital of Xi'an Jiaotong University |
| Xi'an | Shaanxi Provincial People's Hospital |
| Shanghai | Shanghai Mental Health Center |
| Shanghai | Huashan Hospital, Fudan University |
| Shanghai | Renji Hospital, Shanghai Jiao Tong University |
| Shanghai | Pudong Hospital, Fudan University |
| Taiyuan | Shanxi Bethune Hospital |
| Taiyuan | First Hospital of Shanxi Medical University |
| Tianjin | General Hospital, Tianjin Medical University |
| Tianjin | Tianjin Huanhu Hospital |
| Tianjin | Tianjin People's Hospital |
| Hangzhou | Second Affiliated Hospital, Zhejiang University |
| Hangzhou | Affiliated Hospital of Hangzhou Normal University |

Mechanism of Action

[Photobiomodulation](/therapeutics/photobiomodulation-therapy) using near-infrared (NIR) light operates through distinct mechanisms from bright light therapy:

Photobiomodulation Mechanisms

Mitochondrial enhancement: NIR light (600-1000 nm) penetrates tissue and is absorbed by cytochrome c oxidase, enhancing ATP production

Cytochrome c oxidase activation: NIR wavelengths specifically stimulate this key enzyme in the mitochondrial electron transport chain

Reduced oxidative stress: Increased activity of antioxidant enzymes, reduced reactive oxygen species

Anti-inflammatory effects: Modulation of cytokine production and microglial activation

Neuroprotection: Promotion of neurotrophic factors (BDNF, GDNF) and enhancement of autophagy

Improved cerebral blood flow: NIR light may enhance vascular function and blood flow

Rationale for NIR in AD

Near-infrared light offers advantages for Alzheimer's disease:

Deep tissue penetration: Longer wavelengths penetrate deeper into brain tissue
Amyloid clearance: Preclinical studies suggest PBM may reduce amyloid-beta burden
Neuronal survival: Protection against amyloid-beta and tau-induced neurotoxicity
Mitochondrial dysfunction: Addresses the well-documented mitochondrial impairment in AD

Significance

This Phase 3 trial represents a significant step for non-pharmacological neuroprotection in Alzheimer's disease:

Large-scale evidence: 320-patient enrollment provides robust statistical power

Rigorous design: Double-blind, sham-controlled design minimizes bias

Comprehensive outcomes: Multiple cognitive and functional measures

Home-based treatment: Participants complete treatment at home, improving accessibility

Disease modification potential: Unlike symptomatic drugs, PBM may modify disease progression

[Photobiomodulation for Alzheimer's Disease](/therapeutics/photobiomodulation-neurodegeneration)
[Photobiomodulation Therapy Overview](/therapeutics/photobiomodulation-therapy)
[Neuroprotection in Alzheimer's Disease](/therapeutics/neuroprotection)
[Near-Infrared Light Therapy Research](/mechanisms/quantum-biology-neurodegeneration)
[Clinical Trials in Alzheimer's Disease](/clinical-trials/alzheimers-disease)

References

[NCT07262645 - Near-infrared Light Therapy Device for Mild-Moderate Alzheimer's Disease](https://clinicaltrials.gov/study/NCT07262645)

[Photobiomodulation for Alzheimer's Disease - NeuroWiki](/therapeutics/photobiomodulation-neurodegeneration)

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NCT07262645: Near-Infrared Light Therapy for Mild-Moderate Alzheimer's Disease

Near-Infrared Light Therapy for Mild-Moderate Alzheimer's Disease

Trial Overview

Intervention

Study Design

Near-Infrared Light Therapy for Mild-Moderate Alzheimer's Disease

Trial Overview

Intervention

Study Design

Outcomes

Primary Outcomes

Secondary Outcomes

Eligibility

Inclusion Criteria

Exclusion Criteria

Participating Sites

Mechanism of Action

Photobiomodulation Mechanisms

Rationale for NIR in AD

Significance

Related Pages

References