Overview

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.

Eligibility

Inclusion Criteria:

1. Age between 50 and 90 years old, gender unrestricted;
2. 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);
3. Amyloid positivity confirmed by Amyloid PET;
4. Clinical Dementia Rating - Global Score (CDR-GS) rating = 1;
5. Mini-Mental State Examination (MMSE) score ≥ 15;
6. 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;
7. 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);
8. The participant or their guardian voluntarily agrees to participate and signs the informed consent form.
9. 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 Criteria:

1. Cognitive impairment or dementia due to any cause other than Alzheimer's disease, or severe psychiatric disorders (schizophrenia, bipolar disorder, severe depression, etc.);
2. APOE genotype of ε4/ε4;
3. More than 5 cerebral microbleeds in the cerebral cortex as indicated by MRI within the last three months;
4. Currently taking anticoagulant medications;
5. History of epilepsy or hemorrhagic stroke within the past 12 months;
6. Allergy to sunlight or visible light, or high sensitivity of the skin on the head and neck;
7. Severe head trauma or presence of implanted devices (bone screws, bone plates, surgical removals, etc.);
8. Malignant tumors;
9. 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;
10. Contraindications to PET or MRI, including claustrophobia, cardiac pacemaker/defibrillator, ferromagnetic metal implants, etc.;
11. Currently receiving anti-amyloid treatment for Alzheimer's disease with severe adverse reactions such as cerebral hemorrhage or cerebral edema;
12. Alcohol or drug addiction;
13. Pregnant, breastfeeding, or planning to become pregnant;
14. Participation in another clinical study within one month prior to this trial;
15. Other situations deemed by the investigator as unsuitable for participation in the clinical study.
16. For caregivers, the following exclusion criterion applies: They must not have severe neurological or psychiatric disorders.