New light therapy combo aims to slow Alzheimer's
NCT ID NCT06992804
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial is testing whether combining near-infrared light therapy with the drug lecanemab can improve cognitive function in people with mild Alzheimer's disease. Twenty participants will be randomly assigned to receive either real light therapy plus lecanemab or a sham light therapy plus lecanemab for 16 weeks, followed by an open-label extension where everyone gets the real light therapy for up to 48 weeks. The study focuses on safety and changes in cognitive scores.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- near-infrared light therapy and lecanemab
- What this could lead to
- If it works, this could point toward a new combination treatment that slows cognitive decline in mild Alzheimer's disease.
- What could go wrong
- This is a very early, small trial with only 20 participants. The results may not be conclusive, and the treatment could have side effects or no benefit over lecanemab alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xuanwu Hospital, Capital Medical University
RECRUITINGBeijing, 100053, China
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