Status:
RECRUITING
Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-90 years
Phase:
EARLY_PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Age between 50 and 90 years old, gender unrestricted;
- Meet the core clinical diagnostic criteria for probable Alzheimer's disease as defined by the National Institute on Aging and the Alzheimer's Association (2011 NIA-AA);
- Amyloid positivity confirmed by Amyloid PET;
- Clinical Dementia Rating - Global Score (CDR-GS) rating = 1;
- Mini-Mental State Examination (MMSE) score ≥ 15;
- Participants must have an educational level of primary school or above and be capable of completing the cognitive assessments and other tests as specified in the protocol;
- If taking cognition-enhancing medications, the dosage must have been stable for at least 12 weeks prior to enrollment (psychotropic drug dosage stable for at least 4 weeks);
- The participant or their guardian voluntarily agrees to participate and signs the informed consent form.
- For caregivers, the following requirements must be met: They need to be stable and have the ability to read. A minimum of 1 hour of daily interaction with the participant is necessary. Throughout the study, they are expected to assist in completing the informant sections of the scale assessments. Additionally, they should be willing to help the participant use the near-infrared light therapy device. Finally, they must understand and agree to the study procedures.
Exclusion
- Cognitive impairment or dementia due to any cause other than Alzheimer's disease, or severe psychiatric disorders (schizophrenia, bipolar disorder, severe depression, etc.);
- APOE genotype of ε4/ε4;
- More than 5 cerebral microbleeds in the cerebral cortex as indicated by MRI within the last three months;
- Currently taking anticoagulant medications;
- History of epilepsy or hemorrhagic stroke within the past 12 months;
- Allergy to sunlight or visible light, or high sensitivity of the skin on the head and neck;
- Severe head trauma or presence of implanted devices (bone screws, bone plates, surgical removals, etc.);
- Malignant tumors;
- Any unstable and uncontrolled medical conditions (such as severe cardiac, respiratory, gastrointestinal, renal diseases), or conditions that the investigator deems may affect the safety of the patient or interfere with trial assessments;
- Contraindications to PET or MRI, including claustrophobia, cardiac pacemaker/defibrillator, ferromagnetic metal implants, etc.;
- Currently receiving anti-amyloid treatment for Alzheimer's disease with severe adverse reactions such as cerebral hemorrhage or cerebral edema;
- Alcohol or drug addiction;
- Pregnant, breastfeeding, or planning to become pregnant;
- Participation in another clinical study within one month prior to this trial;
- Other situations deemed by the investigator as unsuitable for participation in the clinical study.
- For caregivers, the following exclusion criterion applies: They must not have severe neurological or psychiatric disorders.
Key Trial Info
Start Date :
May 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06992804
Start Date
May 28 2025
End Date
January 20 2027
Last Update
September 9 2025
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053