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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Xuanwu Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yi Tang, MD, PhD
• Email: tangyi@xwhosp.org
• Phone: 00861083199456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.