Actively Recruiting
Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease
Led by Xuanwu Hospital, Beijing · Updated on 2025-09-09
20
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to explore the efficacy and safety of near-infrared light combined with lecanemab in patients with mild Alzheimer's disease (AD). This study will employ a randomized, double-blind, sham-controlled method with an open-label extension phase. This trial contains the core phase and an extension phase. During the core phase, eligible subjects were selected and randomized (experimental group: control group = 1:1). The subjects who entered the experimental group received treatment with a near-infrared light therapy device combined with lecanemab for 16 weeks. The subjects who entered the control group received treatment with a near-infrared light therapy device simulator (sham stimulation) combined with lecanemab for 16 weeks. After completing the core phase, patients from both groups of the core phase are eligible to enter the extension phase. In the extension phase, all the participants were treated with a near-infrared light therapy device combined with lecanemab up to week 48.
CONDITIONS
Official Title
Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 90 years old, any gender
- Diagnosis of probable Alzheimer's disease based on 2011 National Institute on Aging and Alzheimer's Association criteria
- Amyloid positivity confirmed by Amyloid PET scan
- Clinical Dementia Rating - Global Score of 1
- Mini-Mental State Examination score of 15 or higher
- Education level of primary school or above, able to complete cognitive and other tests
- Stable dosage of cognition-enhancing medications for at least 12 weeks prior to enrollment
- Participant or guardian voluntarily consents to participate
- Caregiver is stable, able to read, interacts at least 1 hour daily with participant, assists with assessments and device use, and agrees to study procedures
You will not qualify if you...
- Cognitive impairment or dementia from causes other than Alzheimer's disease, or severe psychiatric disorders
- APOE genotype 4/4
- More than 5 cerebral microbleeds in cerebral cortex on MRI within last 3 months
- Currently taking anticoagulant medications
- History of epilepsy or hemorrhagic stroke within past 12 months
- Allergy or high sensitivity to sunlight or visible light on head and neck skin
- Severe head trauma or presence of implanted devices like bone screws or plates
- Malignant tumors
- Unstable or uncontrolled medical conditions that may affect safety or interfere with assessments
- Contraindications to PET or MRI, including claustrophobia or metal implants
- Currently receiving anti-amyloid treatment with severe adverse reactions like cerebral hemorrhage or edema
- Alcohol or drug addiction
- Pregnant, breastfeeding, or planning pregnancy
- Participation in another clinical trial within one month before this study
- Caregiver with severe neurological or psychiatric disorders
- Any other condition deemed unsuitable by the investigator for participation in the clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053
Actively Recruiting
Research Team
Y
Yi Tang, MD, PhD
CONTACT
L
Liyang Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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