Actively Recruiting
Near-infrared Light Therapy Device for Mild-Moderate Alzheimer's Disease (NirsCure-03A)
Led by Danyang Huichuang Medical Equipment Co., Ltd. · Updated on 2025-12-03
320
Participants Needed
23
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, double-blind, placebo (sham device)-controlled clinical trial. A total of 320 patients with mild to moderate Alzheimer's disease (AD) are planned to be enrolled. Central stratified block randomization will be applied, with stratification based on disease severity (mild vs. moderate) and PET subgroup participation status (yes vs. no). Participants will be randomly assigned to either the treatment group or control group in a 1:1 ratio. After enrollment, participants will complete the treatment at home. The treatment group will receive therapy using a near-infrared light therapy device, while the control group will use sham device. Both investigators and participants will remain blinded to treatment allocation throughout the study.
CONDITIONS
Official Title
Near-infrared Light Therapy Device for Mild-Moderate Alzheimer's Disease (NirsCure-03A)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged between 50 to 85 years old (inclusive).
- At least 4 years of formal education and able to complete cognitive and other assessments.
- Documented progressive memory decline for 12 months or more before screening.
- Meet core clinical diagnostic criteria for mild to moderate Alzheimer's disease dementia (stages 4-5) per NIA-AA 2018 and AA 2024 update.
- Evidence of positive brain amyloid pathology by positive Ab2-PET scan or cerebrospinal fluid Ab2 test.
- Mini-Mental State Examination score between 15 and 26 inclusive (or 12 to 22 if elementary school education).
- Clinical Dementia Rating Global score of 1 or 2, with Memory Box score e 0.5.
- Stable dose of acetylcholinesterase inhibitor or memantine for at least 12 weeks if currently treated.
- Have a reliable study partner who can support daily treatment and communicate with study staff.
- Provide written informed consent voluntarily before any study procedures.
You will not qualify if you...
- Diagnosis other than Alzheimer's disease that may cause dementia or cognitive decline (e.g., vascular dementia, CNS infections, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic brain injury-related dementia, or dementia due to physical or chemical factors).
- Brain MRI showing significant abnormalities such as multiple large infarcts, extensive white matter changes, or space-occupying lesions (except small meningiomas or arachnoid cysts under 1 cm).
- History of transient ischemic attack, stroke, or seizure within 6 months prior to screening.
- Hachinski Ischemic Score greater than 4.
- Hamilton Depression Rating Scale score greater than 10.
- Diagnosis of psychiatric disorders including schizophrenia, bipolar disorder, major depression, or delirium.
- Known HIV infection or neurosyphilis.
- Severe cardiovascular disease or recent unstable angina or myocardial infarction.
- Severe dysfunction of major organs or any condition making participation unsafe.
- Prior or current treatment with anti-amyloid monoclonal antibodies.
- Prior or planned lymphaticovenous anastomosis of cervical deep lymphatic vessels.
- Participation in other interventional trials within 30 days before screening.
- History of severe head trauma or implanted cranial devices or contraindications to MRI.
- Contraindications or allergy to PET tracer or FDG tracer for PET substudy.
- History of malignancy within 5 years (with some exceptions for adequately treated cancers).
- Women who are pregnant, breastfeeding, planning pregnancy, or not using effective contraception.
- Any other condition deemed by the investigator to interfere with safety or study compliance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
2
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
3
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
4
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
5
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
6
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
7
Baotou Central Hospital
Baotou, Inner Mongolia, China, 014040
Actively Recruiting
8
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
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9
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
10
Tangdu Hospital, Air Force Medical University
Xi'an, Shaanxi, China, 710038
Actively Recruiting
11
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
12
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China, 710068
Actively Recruiting
13
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
14
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
15
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
16
Pudong Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 201399
Actively Recruiting
17
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030001
Actively Recruiting
18
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Actively Recruiting
19
General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
20
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
21
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300121
Actively Recruiting
22
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
23
Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China, 310015
Actively Recruiting
Research Team
Y
Yi Tang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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