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New light therapy combo aims to slow Alzheimer's

NCT ID NCT06992804

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

50 to 90 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Xuanwu Hospital, Capital Medical University

    RECRUITING

    Beijing, 100053, China

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