Alzheimer DiseaseEarly Phase 1NCT06992804
Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease
A Early Phase 1 study testing NirsCure with Lecanemab in people with Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- NirsCure with Lecanemab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2025to 20 Jan 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 and 90 years old, gender unrestricted;
- 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);
- Amyloid positivity confirmed by Amyloid PET;
- Clinical Dementia Rating - Global Score (CDR-GS) rating = 1;
- Mini-Mental State Examination (MMSE) score ≥ 15;
- 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;
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- 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);
- The participant or their guardian voluntarily agrees to participate and signs the informed consent form.
- 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.
Who cannot join
- Cognitive impairment or dementia due to any cause other than Alzheimer's disease, or severe psychiatric disorders (schizophrenia, bipolar disorder, severe depression, etc.);
- APOE genotype of ε4/ε4;
- More than 5 cerebral microbleeds in the cerebral cortex as indicated by MRI within the last three months;
- Currently taking anticoagulant medications;
- History of epilepsy or hemorrhagic stroke within the past 12 months;
- Allergy to sunlight or visible light, or high sensitivity of the skin on the head and neck;
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- Severe head trauma or presence of implanted devices (bone screws, bone plates, surgical removals, etc.);
- Malignant tumors;
- 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;
- Contraindications to PET or MRI, including claustrophobia, cardiac pacemaker/defibrillator, ferromagnetic metal implants, etc.;
- Currently receiving anti-amyloid treatment for Alzheimer's disease with severe adverse reactions such as cerebral hemorrhage or cerebral edema;
- Alcohol or drug addiction;
- Pregnant, breastfeeding, or planning to become pregnant;
- Participation in another clinical study within one month prior to this trial;
- Other situations deemed by the investigator as unsuitable for participation in the clinical study.
- For caregivers, the following exclusion criterion applies: They must not have severe neurological or psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Yi Tang, MD, PhD, 00861083199456, tangyixw@vip.163.com
About this study
Official title: The Efficacy and Safety of Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease
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.
- Conditions
- Alzheimer Disease
- Being tested
- NirsCure with Lecanemab, sham NirsCure with Lecanemab
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NirsCure with LecanemabOther
Near-infrared light therapy (one session per day, 30 minutes per session, 6 sessions per week) combined with lecanemab (10mg/kg).
sham NirsCure with LecanemabOther
Sham near-infrared light therapy (where only the equipment appearance is consistent with the true near infrared light device, one session per day, 30 minutes per session, 6 sessions per week) in combined with lecanemab (10mg/kg).
NirsCure with LecanemabOther
Near-infrared light therapy (one session per day, 30 minutes per session, 6 sessions per week) combined with lecanemab (10mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| Core phase: Near infrared light therapy with lecanemab | Experimental | Not described Receives: Other: NirsCure with Lecanemab |
| Core phase: Sham irradiation with lecanemab | Placebo comparator | Not described Receives: Other: sham NirsCure with Lecanemab |
| Extension phase: Near infrared light therapy with lecanemab | Experimental | This arm includes participants who finish the core phase and are willing to take part in the extension phase. Receives: Other: NirsCure with Lecanemab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog).
The Alzheimer's Disease Assessment Scale - Cognitive Section (ADAS-Cog-14) is a comprehensive tool used to evaluate cognitive function in individuals. The unabbreviated scale title is the Alzheimer's Disease Assessment Scale - Cognitive Section. The minimum score on this scale is 0, while the maximum score is 144. Importantly, higher scores on the ADAS-Cog-14 indicate worse cognitive function. This scale assesses various cognitive domains, and an increasing score reflects more severe cognitive impairment.
Measured: 16 weeks.
Secondary outcomes (12)
The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog).
The Alzheimer's Disease Assessment Scale - Cognitive Section (ADAS-Cog-14) is a comprehensive tool used to evaluate cognitive function in individuals. The unabbreviated scale title is the Alzheimer's Disease Assessment Scale - Cognitive Section. The minimum score on this scale is 0, while the maximum score is 144. Importantly, higher scores on the ADAS-Cog-14 indicate worse cognitive function. This scale assesses various cognitive domains, and an increasing score reflects more severe cognitive impairment.
Measured: 32 weeks, 48 weeks.
The change from baseline in the Mini-Mental State Examination (MMSE).
The Mini-Mental State Examination (MMSE) is a widely used tool for assessing cognitive function. The unabbreviated scale title is the Mini-Mental State Examination. The minimum score on this scale is 0, while the maximum score is 30. Higher scores on the MMSE indicate better cognitive function. This scale evaluates various cognitive domains such as orientation, attention, calculation, recall, and language. A higher score reflects better cognitive performance.
Measured: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB).
The Clinical Dementia Rating - Sum of Boxes (CDR-SB) is a comprehensive assessment tool used to evaluate the severity of dementia. The unabbreviated scale title is the Clinical Dementia Rating - Sum of Boxes. The minimum score on this scale is 0, while the maximum score is 18. Higher scores on the CDR-SB indicate worse cognitive and functional impairment. This scale assesses various domains including memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care. An increasing score reflects more severe dementia.
Measured: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL).
The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL) is a tool designed to assess the functional abilities of individuals in their daily activities. The unabbreviated scale title is the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale. The minimum score on this scale is 0, while the maximum score is 78. Higher scores on the ADCS-ADL indicate better functional ability in daily living activities. This scale evaluates various aspects of daily living, such as personal care, household chores, and financial management. A higher score reflects better performance in activities of daily living.
Measured: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Neuropsychiatric Inventory (NPI).
The Neuropsychiatric Inventory (NPI) is a comprehensive assessment tool used to evaluate behavioral and psychiatric symptoms in individuals with cognitive disorders. The unabbreviated scale title is the Neuropsychiatric Inventory. The minimum score on this scale is 0, while the maximum score is 144. Higher scores on the NPI indicate more severe behavioral and psychiatric symptoms. This scale assesses various domains including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, and motor disturbance. An increasing score reflects more significant behavioral and psychiatric disturbances.
Measured: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Hamilton Depression Rating Scale (HAMD).
The Hamilton Depression Rating Scale (HAMD) is a widely used tool for assessing the severity of depressive symptoms in individuals. The unabbreviated scale title is the Hamilton Depression Rating Scale. The minimum score on this scale is 0, while the maximum score is 52 (for the 17-item version). Higher scores on the HAMD indicate more severe depressive symptoms. This scale evaluates various aspects of depression, including mood, guilt, suicide, insomnia, agitation, anxiety, somatic symptoms, and weight loss. An increasing score reflects more significant depressive symptomatology.
Measured: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC).
The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a tool used to assess the overall change in clinical status of individuals with Alzheimer's disease. The unabbreviated scale title is the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change. The scale ranges from 1 to 7, with 1 indicating "Very much improved" and 7 indicating "Very much worse." A score of 4 represents "No change." Lower scores on the ADCS-CGIC indicate better clinical outcomes, reflecting improvement or stabilization, while higher scores indicate worsening clinical status. This scale provides a global assessment of change based on the clinician's judgment of the patient's overall condition.
Measured: 16 weeks, 32 weeks, 48 weeks.
The change from baseline levels measured by Positron Emission Tomography (PET).
Measured: 16 weeks, 48 weeks.
The change from baseline as measured by Magnetic Resonance Imaging (MRI).
Measured: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in blood biomarker measurements.
Concentration of Abeta-40, Abeta-42, t-tau, p-tau181, p-tau217, GFAP, NFL
Measured: 16 weeks, 32 weeks, 48 weeks.
The change from baseline as measured by EEG power across different frequency bands.
This outcome measure assesses changes in EEG power across different frequency bands, including Delta (1-4 Hz), Theta (4-8 Hz), Alpha (8-12 Hz), Beta (12-30 Hz), and Gamma (30-100 Hz). EEG recordings will be taken at baseline and at specified time points during the study to evaluate changes in brain activity.
Power: µV²/Hz
Higher power in specific frequency bands may indicate increased brain activity, while lower power may suggest decreased activity. The clinical significance of changes in EEG power will be interpreted based on the study objectives and relevant clinical standards.
Measured: 16 weeks, 32 weeks, 48 weeks.
Safety indicators/adverse events.
Measured: 16 weeks, 32 weeks, 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start28 May 2025
- Primary completion15 Oct 2025 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Tang, MD, PhD, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992804
- Sponsor's protocol ID
- 2024346
- Status last verified
- May 2025
- First submitted
- 18 Mar 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06992804
- Acronym / sponsor ID
- 2024346
- Conditions
- Alzheimer Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core phase: Near infrared light therapy with lecanemab | Experimental | Other: NirsCure with Lecanemab |
| Core phase: Sham irradiation with lecanemab | Placebo comparator | Other: sham NirsCure with Lecanemab |
| Extension phase: Near infrared light therapy with lecanemab | Experimental | Other: NirsCure with LecanemabThis arm includes participants who finish the core phase and are willing to take part in the extension phase. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 50 and 90 years old, gender unrestricted;
- 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);
- Amyloid positivity confirmed by Amyloid PET;
- Clinical Dementia Rating - Global Score (CDR-GS) rating = 1;
- Mini-Mental State Examination (MMSE) score ≥ 15;
Key exclusion criteria (16 listed)
- Cognitive impairment or dementia due to any cause other than Alzheimer's disease, or severe psychiatric disorders (schizophrenia, bipolar disorder, severe depression, etc.);
- APOE genotype of ε4/ε4;
- More than 5 cerebral microbleeds in the cerebral cortex as indicated by MRI within the last three months;
- Currently taking anticoagulant medications;
- History of epilepsy or hemorrhagic stroke within the past 12 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NirsCure with LecanemabNear-infrared light therapy (one session per day, 30 minutes per session, 6 sessions per week) combined with lecanemab (10mg/kg). | Other | Core phase: Near infrared light therapy with lecanemab |
| sham NirsCure with LecanemabSham near-infrared light therapy (where only the equipment appearance is consistent with the true near infrared light device, one session per day, 30 minutes per session, 6 sessions per week) in combined with lecanemab (10mg/kg). | Other | Core phase: Sham irradiation with lecanemab |
| NirsCure with LecanemabNear-infrared light therapy (one session per day, 30 minutes per session, 6 sessions per week) combined with lecanemab (10mg/kg). | Other | Extension phase: Near infrared light therapy with lecanemab |
Primary outcome
The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog).
Time frame: 16 weeks.
The Alzheimer's Disease Assessment Scale - Cognitive Section (ADAS-Cog-14) is a comprehensive tool used to evaluate cognitive function in individuals. The unabbreviated scale title is the Alzheimer's Disease Assessment Scale - Cognitive Section. The minimum score on this scale is 0, while the maximum score is 144. Importantly, higher scores on the ADAS-Cog-14 indicate worse cognitive function. This scale assesses various cognitive domains, and an increasing score reflects more severe cognitive impairment.
12 secondary outcomes
The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog).
Time frame: 32 weeks, 48 weeks.
The change from baseline in the Mini-Mental State Examination (MMSE).
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB).
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL).
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Neuropsychiatric Inventory (NPI).
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Hamilton Depression Rating Scale (HAMD).
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC).
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline levels measured by Positron Emission Tomography (PET).
Time frame: 16 weeks, 48 weeks.
The change from baseline as measured by Magnetic Resonance Imaging (MRI).
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline in blood biomarker measurements.
Time frame: 16 weeks, 32 weeks, 48 weeks.
The change from baseline as measured by EEG power across different frequency bands.
Time frame: 16 weeks, 32 weeks, 48 weeks.
Safety indicators/adverse events.
Time frame: 16 weeks, 32 weeks, 48 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi Tang, MD, PhD study chair
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NirsCure with Lecanemab in people with Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Tang, MD, PhD (00861083199456, tangyi@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog). (time frame: 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.