Alzheimer DiseaseEarly Phase 1NCT06836180
An Exploratory Study of Near-infrared Light Therapy for Mild to Moderate Alzheimer's Disease
A Early Phase 1 study testing Near infrared light therapy in people with Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This is an exploratory clinical study to evaluate the efficacy and safety of near-infrared light therapeutics in the treatment of mild to moderate Alzheimer's disease. 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?
- Near infrared light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2025to 31 Dec 2030
- 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
- 50 - 90 years old, no gender limitation;
- Meeting the National Institute on Aging and Alzheimer's Association (2011 NIA-AA) is likely the core clinical diagnostic criteria for Alzheimer's disease;
- The MMSE score is ≥ 12 and ≤ 26;
- The subjects should have primary school education or above and be able to complete the cognitive ability measurement and other tests stipulated in the protocol;
- If taking cognitive-improving medications, the dose must be stable for at least 12 weeks prior to enrollment (stable for at least 4 weeks with psychotropic medications);
- Participants themselves or their guardians voluntarily participate and sign the informed consent.
Who cannot join
- Any cognitive impairment or dementia not caused by Alzheimer's disease, or co-existing with a serious mental illness (schizophrenia, bipolar disorder, major depression, etc.);
- Currently taking anticoagulant drugs;
- A history of seizures or hemorrhagic stroke within 12 months;
- Allergic to sunlight or visible light or high sensitivity to head and neck skin;
- Severe head trauma or implants (bone nails, bone plates, excision, etc.);
- Malignant tumors;
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- Any other medical condition that is not stabilized and adequately controlled (such as serious heart, respiratory, gastrointestinal, or kidney disease), or that the investigator believes may affect patient safety or interfere with the evaluation of the test;
- Persons addicted to alcohol or drugs;
- Women who are pregnant, nursing or planning a pregnancy;
- Participated in other clinical studies within 1 month before participating in this trial;
- Other conditions deemed unsuitable for clinical trial participation by the investigator.
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
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Yi Tang, MD, PhD, 0086+1083199456, tangyixw@vip.163.com
About this study
This is an exploratory clinical study to evaluate the efficacy and safety of near-infrared light therapeutics in the treatment of mild to moderate Alzheimer's disease.
Read the detailed description
This experiment adopts a single-center, single-arm research design. All the patients who signed the informed consent were screened, and qualified subjects could only be enrolled to receive NIR therapy. This study plans to enroll 40 patients, all of whom meet the enrollment conditions will receive NIR therapy, and the treatment is arranged to be once a day, once a 30min NIR therapy, 6 times a week. The treatment lasted for 96 weeks, and follow-up and assessment were performed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, 96 weeks. During the first week of treatment, caregivers will be trained in the use of the NIR device, and after the training is complete, researchers will also provide remote guidance, making visits as needed. Changes in the 96-week ADAS-cog score from baseline were used as the primary endpoint to verify the efficacy and safety of the NIR device.
- Conditions
- Alzheimer Disease
- Being tested
- Near infrared light therapy
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared light therapyDevice
Once a day, once 30 minutes of near-infrared light treatment, 6 times a week for 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Once a day, once 30 minutes of near-infrared light treatment, 6 times a week for 96 weeks Receives: Device: Near infrared light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Measured: baseline, 96 weeks
Secondary outcomes (5)
ADAS-Cog
change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Measured: baseline,12 weeks,24 weeks,36 weeks,48 weeks, 60 weeks, 72 weeks, 84 weeks
Mini Mental state Examination (MMSE)
change from baseline on the Mini Mental state Examination (MMSE) score
Measured: baseline,12 weeks,24 weeks,36 weeks,48 weeks, 60 weeks, 72 weeks, 84 weeks, 96 weeks
Quantification of T-cell Subpopulation Proportions in Cerebrospinal Fluid (CSF) via Single-Cell RNA Sequencing
To determine the proportional abundance of T-cell subsets (e.g., CD4+, CD8+, regulatory T cells) within the cerebrospinal fluid (CSF) of patients using single-cell RNA sequencing (scRNA-seq).
Measured: baseline, 12 weeks
Comprehensive Profiling of Glycolytic and Lipid Metabolic Substrates in Cerebrospinal Fluid (CSF) via Metabolomics
To quantify the concentrations of key metabolites involved in glycolysis (e.g., glucose, lactate, pyruvate) and lipid metabolism (e.g., free fatty acids, acylcarnitines, phospholipids) in cerebrospinal fluid (CSF) using liquid chromatography-tandem mass spectrometry (LC-MS/MS)-based metabolomics.
Measured: baseline, 12 weeks
Quantification of Alzheimer's Disease (AD)-Associated Pathogenic Proteins in Cerebrospinal Fluid (CSF) via Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
To measure the concentration of AD-related neurotoxic proteins (e.g., amyloid-beta 42 [Aβ42], total tau, phosphorylated tau [p-tau181/217], neurofilament light chain [NfL]) in cerebrospinal fluid (CSF) using high-sensitivity liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start30 Oct 2025 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion31 Dec 2030 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836180
- Sponsor's protocol ID
- 2024443
- Status last verified
- Apr 2025
- First submitted
- 12 Jan 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Near-infrared Light Therapy for Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06836180
- Acronym / sponsor ID
- 2024443
- Conditions
- Alzheimer Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Feb 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.
This is an exploratory clinical study to evaluate the efficacy and safety of near-infrared light therapeutics in the treatment of mild to moderate Alzheimer's disease.
Detailed description
This experiment adopts a single-center, single-arm research design. All the patients who signed the informed consent were screened, and qualified subjects could only be enrolled to receive NIR therapy. This study plans to enroll 40 patients, all of whom meet the enrollment conditions will receive NIR therapy, and the treatment is arranged to be once a day, once a 30min NIR therapy, 6 times a week. The treatment lasted for 96 weeks, and follow-up and assessment were performed at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks, 96 weeks. During the first week of treatment, caregivers will be trained in the use of the NIR device, and after the training is complete, researchers will also provide remote guidance, making visits as needed. Changes in the 96-week ADAS-cog score from baseline were used as the primary endpoint to verify the efficacy and safety of the NIR device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Near infrared light therapyOnce a day, once 30 minutes of near-infrared light treatment, 6 times a week for 96 weeks |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 50 - 90 years old, no gender limitation;
- Meeting the National Institute on Aging and Alzheimer's Association (2011 NIA-AA) is likely the core clinical diagnostic criteria for Alzheimer's disease;
- The MMSE score is ≥ 12 and ≤ 26;
- The subjects should have primary school education or above and be able to complete the cognitive ability measurement and other tests stipulated in the protocol;
- If taking cognitive-improving medications, the dose must be stable for at least 12 weeks prior to enrollment (stable for at least 4 weeks with psychotropic medications);
Key exclusion criteria (11 listed)
- Any cognitive impairment or dementia not caused by Alzheimer's disease, or co-existing with a serious mental illness (schizophrenia, bipolar disorder, major depression, etc.);
- Currently taking anticoagulant drugs;
- A history of seizures or hemorrhagic stroke within 12 months;
- Allergic to sunlight or visible light or high sensitivity to head and neck skin;
- Severe head trauma or implants (bone nails, bone plates, excision, etc.);
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 |
|---|---|---|
| Near infrared light therapyOnce a day, once 30 minutes of near-infrared light treatment, 6 times a week for 96 weeks | Device | Intervention group |
Primary outcome
Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Time frame: baseline, 96 weeks
change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
5 secondary outcomes
ADAS-Cog
Time frame: baseline,12 weeks,24 weeks,36 weeks,48 weeks, 60 weeks, 72 weeks, 84 weeks
Mini Mental state Examination (MMSE)
Time frame: baseline,12 weeks,24 weeks,36 weeks,48 weeks, 60 weeks, 72 weeks, 84 weeks, 96 weeks
Quantification of T-cell Subpopulation Proportions in Cerebrospinal Fluid (CSF) via Single-Cell RNA Sequencing
Time frame: baseline, 12 weeks
Comprehensive Profiling of Glycolytic and Lipid Metabolic Substrates in Cerebrospinal Fluid (CSF) via Metabolomics
Time frame: baseline, 12 weeks
Quantification of Alzheimer's Disease (AD)-Associated Pathogenic Proteins in Cerebrospinal Fluid (CSF) via Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Time frame: baseline, 12 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 15 Sep 2025.
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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.
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 Near infrared light therapy 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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 15 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. 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 (0086+1083199456, tangyi@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's disease assessment scale-cognitive section(ADAS-Cog) (time frame: baseline, 96 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 15 Sep 2025.