Can a light cap slow Alzheimer's? new trial tests it
NCT ID NCT06160908
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether shining near-infrared light on the head (a device called NirsCure) can safely help people with mild-to-moderate Alzheimer's disease. 38 participants will either get real light or a sham treatment for 16 weeks, then everyone can get the real light for up to 196 weeks. The goal is to see if this light therapy can slow down memory and thinking problems.
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 (device)
- What this could lead to
- If it works, this could offer a non-drug way to slow cognitive decline in Alzheimer's disease.
- What could go wrong
- This is a small, early-stage trial with only 38 people. The effect may be small or no better than placebo, and long-term benefits are uncertain.
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
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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38 people
The number who actually took part.
- Started
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Dec 2023
- Expected to finish
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Jun 2028
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. 50 - 90 years old, no gender limitation; 2. Meeting clinical diagnostic criteria of probable AD according to National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines; 3. Clinical Dementia Rating Scale Total Score (CDR-GS) score ≥ 1 and ≤ 2, Clinical Dementia Rating Scale Memory Box score ≥ 0.5; 4. Amyloid PET or cerebrospinal fluid examination or blood biomarkers conforms to changes in AD biomarkers; 5. The MMSE score is ≥ 12 and ≤ 26; 6. Education level is non illiterate or has received cultural education for 4-6 years or more; 7. 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; 8. 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); 9. Subjects with informed consent; Exclusion Criteria: 1. Any neurological and psychiatric symptoms beyond the scope of symptoms that can be caused by Alzheimer's disease; 2. A history of transient ischemic attack (TIA), stroke, or epilepsy within 12 months; 3. Any mental diagnosis or symptoms that may interfere with the participant's research process (such as hallucinations, severe depression, or delusions); 4. Contraindications to MRI, including pacemakers/defibrillators, ferromagnetic metal implants, etc; 5. MRI shows other clinically significant lesions, which may indicate the diagnosis of dementia beyond Alzheimer's disease; 6. 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); 7. A photosensitive response to sunlight or visible light, with eczema or increased sensitivity on the skin at the intervention site; 8. Severe visual or hearing impairment; 9. Individuals who are addicted to alcohol, drugs, or other drugs or have a tendency to become addicted; 10. Participating in other AD clinical trials; 11. 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; 12. Other conditions that, in the opinion of the investigator, may not be suitable for this study.
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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.
Contacts and locations
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, 100053, China
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Other studies related to the condition(s) this trial covers.
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