Alzheimer DiseaseNCT06160908
Transcranial Near-infrared Light Therapy for Mild-Moderate Alzheimer's Disease (NIR4AD)
A study testing NirsCure 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 Photobiomodulation in patients with mild-moderate Alzheimer's disease(AD). This study will employ a randomized, double-blind, sham-controlled approach. This trial contains core phase and 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2023to 30 Jun 2028
- Phase
- Interventional
- 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 clinical diagnostic criteria of probable AD according to National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines;
- Clinical Dementia Rating Scale Total Score (CDR-GS) score ≥ 1 and ≤ 2, Clinical Dementia Rating Scale Memory Box score ≥ 0.5;
- Amyloid PET or cerebrospinal fluid examination or blood biomarkers conforms to changes in AD biomarkers;
- The MMSE score is ≥ 12 and ≤ 26;
- Education level is non illiterate or has received cultural education for 4-6 years or more;
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- If taking mental or cognitive improvement drugs, the dosage must be stable for at least 3 months before the study, and remain unchanged during the light regulation intervention period. Unless otherwise specified, participants must consistently use all other (i.e. non Alzheimer's disease related) permitted concomitant medications for at least 4 weeks before baseline;
- Having a designated guardian or caregiver who can assist them in participating in the experiment (defined as someone who can support participants throughout the entire study period and spend at least 8 hours with them per week);
- Subjects with informed consent;
Who cannot join
- Any neurological and psychiatric symptoms beyond the scope of symptoms that can be caused by Alzheimer's disease;
- A history of transient ischemic attack (TIA), stroke, or epilepsy within 12 months;
- Any mental diagnosis or symptoms that may interfere with the participant's research process (such as hallucinations, severe depression, or delusions);
- Contraindications to MRI, including pacemakers/defibrillators, ferromagnetic metal implants, etc;
- MRI shows other clinically significant lesions, which may indicate the diagnosis of dementia beyond Alzheimer's disease;
- MRI shows other important pathological findings, including but not limited to: 4 or more microbleeds with a diameter of 10 millimeters or less; Single bleeding lesion with a maximum diameter greater than 10 millimeters; Surface iron deposition area; Evidence of exudative edema; Evidence of brain contusion, encephalomalacia, aneurysm, vascular malformation, or infectious disease; Multiple lacunar infarcts or strokes involving major vascular areas, severe small vessel or white matter lesions; Space occupying lesions; Or brain tumors (diagnosed as meningiomas or arachnoid cysts, lesions with a maximum diameter of less than 1 cm may not be ruled out);
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- A photosensitive response to sunlight or visible light, with eczema or increased sensitivity on the skin at the intervention site;
- Severe visual or hearing impairment;
- Individuals who are addicted to alcohol, drugs, or other drugs or have a tendency to become addicted;
- Participating in other AD clinical trials;
- Any other medical conditions that are not stable and adequately controlled (such as heart, respiratory, gastrointestinal, kidney diseases), or situations that the researcher believes may affect the safety of participants or interfere with the evaluation of the study;
- Other conditions that, in the opinion of the investigator, may not be suitable for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of Transcranial Near-infrared Light in the Treatment of Mild-Moderate Alzheimer's Disease
The goal of this study is to explore the efficacy and safety of Near-infrared light Photobiomodulation in patients with mild-moderate Alzheimer's disease(AD).
This study will employ a randomized, double-blind, sham-controlled approach. This trial contains core phase and extension phase. In the core phase, qualified subjects were selected and randomized (experimental group: control group=1:1). The subjects who entered the experimental group received 30 minutes of near-infrared light therapy once a day, 6 times a week, for 16 weeks of continuous treatment. The subjects who entered the control group received 30 minutes of non-near-infrared light irradiation once a day (false treatment), 6 times a week, for 16 weeks. After finishing 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 receive active near-infrared light therapy until week 196.
- Conditions
- Alzheimer Disease
- Being tested
- NirsCure, sham NirsCure
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NirsCureDevice
True near-infrared light； Once a day, once for 30 minutes, 6 times a week
sham NirsCureDevice
Non near-infrared light irradiation；only the equipment appearance is consistent with the test device；Once a day, once for 30 minutes, 6 times a week
NirsCureDevice
True near-infrared light； Once a day, once for 30 minutes, 6 times a week
| Study group | Role | What they receive |
|---|---|---|
| Core phase: sham irradiation group. | Sham comparator | Not described Receives: Device: sham NirsCure |
| Core phase: Near infrared light therapy | Experimental | Not described Receives: Device: NirsCure |
| Extension phase: Near infrared light therapy | Experimental | This arm includes participants who finish the core phase from the core phase experimental group and the core phase sham comparator group. The intervention is the same as the intervention in the core phase. Receives: Device: NirsCure |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Measured: 16 weeks
Secondary outcomes (13)
change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Measured: baseline, 8 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Mini Mental state Examination (MMSE) score
Measured: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Measured: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Alzheimer's Disease Cooperative study-clinical global impression of change scale(ADCS-CGIC)
Measured: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Alzheimer's Disease Cooperative study-Activities of Daily Living Scale(ADCS-ADL)
Measured: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Neuropaychiatic Inventory (NPI)
Measured: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Hamilton depression scale (HAMD)
Measured: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
Change from Baseline in Brain Amyloid Plaque Deposition as measured by PET Scan
Measured: baseline,16 weeks, 52 weeks, 76 weeks, 100 weeks, 148 weeks, 196 weeks.
Change from Baseline in FDG-PET imaging
Measured: baseline,16 weeks, 52 weeks, 76 weeks, 100 weeks, 148 weeks, 196 weeks.
Change from Baseline in resting state Electroencephalogram and Event Related Potentials (ERP)
Measured: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
Change from Baseline in resting state near-infrared brain function imaging
Measured: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks.
Change from Baseline in magnetic resonance imaging analysis
Measured: baseline, 8 weeks,16 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
Change from baseline in blood biomarkers.
Measured: baseline, 8 weeks,16 weeks, 52 weeks, 76 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start12 Dec 2023
- Primary completion25 Aug 2024
- Study completion30 Jun 2028 (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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Danyang Huichuang Medical Equipment Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yi Tang, MD., PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160908
- Sponsor's protocol ID
- 2023162
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2023
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Transcranial Near-infrared Light in the Treatment of Mild-Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06160908
- Acronym / sponsor ID
- 2023162
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Danyang Huichuang Medical Equipment Co., Ltd.
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 Dec 2023 (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 Photobiomodulation in patients with mild-moderate Alzheimer's disease(AD).
This study will employ a randomized, double-blind, sham-controlled approach. This trial contains core phase and extension phase. In the core phase, qualified subjects were selected and randomized (experimental group: control group=1:1). The subjects who entered the experimental group received 30 minutes of near-infrared light therapy once a day, 6 times a week, for 16 weeks of continuous treatment. The subjects who entered the control group received 30 minutes of non-near-infrared light irradiation once a day (false treatment), 6 times a week, for 16 weeks. After finishing 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 receive active near-infrared light therapy until week 196.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core phase: sham irradiation group. | Sham comparator | Device: sham NirsCure |
| Core phase: Near infrared light therapy | Experimental | Device: NirsCure |
| Extension phase: Near infrared light therapy | Experimental | Device: NirsCureThis arm includes participants who finish the core phase from the core phase experimental group and the core phase sham comparator group. The intervention is the same as the intervention in the core 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)
- 50 - 90 years old, no gender limitation;
- Meeting clinical diagnostic criteria of probable AD according to National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines;
- Clinical Dementia Rating Scale Total Score (CDR-GS) score ≥ 1 and ≤ 2, Clinical Dementia Rating Scale Memory Box score ≥ 0.5;
- Amyloid PET or cerebrospinal fluid examination or blood biomarkers conforms to changes in AD biomarkers;
- The MMSE score is ≥ 12 and ≤ 26;
Key exclusion criteria (12 listed)
- Any neurological and psychiatric symptoms beyond the scope of symptoms that can be caused by Alzheimer's disease;
- A history of transient ischemic attack (TIA), stroke, or epilepsy within 12 months;
- Any mental diagnosis or symptoms that may interfere with the participant's research process (such as hallucinations, severe depression, or delusions);
- Contraindications to MRI, including pacemakers/defibrillators, ferromagnetic metal implants, etc;
- MRI shows other clinically significant lesions, which may indicate the diagnosis of dementia beyond Alzheimer's disease;
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 |
|---|---|---|
| NirsCureTrue near-infrared light； Once a day, once for 30 minutes, 6 times a week | Device | Core phase: Near infrared light therapy |
| sham NirsCureNon near-infrared light irradiation；only the equipment appearance is consistent with the test device；Once a day, once for 30 minutes, 6 times a week | Device | Core phase: sham irradiation group. |
| NirsCureTrue near-infrared light； Once a day, once for 30 minutes, 6 times a week | Device | Extension phase: Near infrared light therapy |
Primary outcome
change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Time frame: 16 weeks
13 secondary outcomes
change from baseline on the Alzheimer's disease assessment scale-cognitive section(ADAS-Cog)
Time frame: baseline, 8 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Mini Mental state Examination (MMSE) score
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Alzheimer's Disease Cooperative study-clinical global impression of change scale(ADCS-CGIC)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Alzheimer's Disease Cooperative study-Activities of Daily Living Scale(ADCS-ADL)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Neuropaychiatic Inventory (NPI)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
change from baseline on the Hamilton depression scale (HAMD)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
Change from Baseline in Brain Amyloid Plaque Deposition as measured by PET Scan
Time frame: baseline,16 weeks, 52 weeks, 76 weeks, 100 weeks, 148 weeks, 196 weeks.
Change from Baseline in FDG-PET imaging
Time frame: baseline,16 weeks, 52 weeks, 76 weeks, 100 weeks, 148 weeks, 196 weeks.
Change from Baseline in resting state Electroencephalogram and Event Related Potentials (ERP)
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
Change from Baseline in resting state near-infrared brain function imaging
Time frame: baseline,8 weeks,16 weeks, 28 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks.
Change from Baseline in magnetic resonance imaging analysis
Time frame: baseline, 8 weeks,16 weeks, 40 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 weeks.
Change from baseline in blood biomarkers.
Time frame: baseline, 8 weeks,16 weeks, 52 weeks, 76 weeks, 100 weeks, 124 weeks, 148 weeks, 172 weeks, 196 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 13 Apr 2026.
- 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. This study is not recruiting at the moment.
Yi Tang, MD., PhD principal investigator
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 study testing NirsCure 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 12 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline on the Alzheimer's disease assessment scale-cognitive section(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 13 Apr 2026.