Near-infrared light plus lecanemab for people with mild Alzheimer's

The Efficacy and Safety of Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease

This trial tests whether adding near-infrared light therapy to lecanemab helps people with mild Alzheimer's disease.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 50 Years to 90 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Drugs / interventions: lecanemab
• Locations: 1 site (Beijing)
• Trial ID: NCT06992804 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, sham-controlled early-phase trial with an open-label extension testing a near-infrared brain stimulation device (NirsCure) combined with lecanemab. In the 16-week core phase participants are randomized 1:1 to active device plus lecanemab or a sham device plus lecanemab, followed by an extension where all participants receive the active device with lecanemab. Eligibility requires biomarker-confirmed (amyloid PET) mild Alzheimer's disease (CDR-GS = 1) and an MMSE score of at least 15. The trial will monitor safety and look for signals of cognitive and functional benefit from the combination therapy.

Who should consider this trial

Good fit: Adults aged 50–90 with amyloid-positive mild Alzheimer's (CDR-GS = 1) who can complete cognitive testing, have an available caregiver, and are stable on any cognition-enhancing medications.

Not a fit: People with moderate-to-severe Alzheimer's, no amyloid on PET, unstable medical or psychiatric conditions, inability to tolerate lecanemab or the device, or who cannot attend required visits are unlikely to benefit.

Why it matters

Potential benefit: If successful, combining near-infrared light therapy with lecanemab could slow cognitive decline or improve memory and daily function for people with mild Alzheimer's.

How similar studies have performed: Lecanemab has shown modest slowing of decline in early Alzheimer's, while near-infrared transcranial therapy remains experimental with limited evidence, and the specific combination is largely novel.

Eligibility criteria

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.

Where this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yi Tang, MD, PhD

Conditions Alzheimer Disease