Under construction – not a live service
Sign in
Taking people in ChinaNo phase

Light therapy for mild cognitive impairment and early Alzheimer's disease

Tests near-infrared light therapy on the head in adults with early memory problems.

Key facts

Who runs it
Jun Xu
Where
Beijing, ChinaSee the site
Trial code
Registry title
Efficacy and Safety of Photobiomodulation Therapy in Patients With Mild Cognitive Impairment and Mild Alzheimer's Disease
Status
Recruiting
People taking part
20 people, planned
Started
15 Jun 2024
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Photobiomodulation
Record updated
22 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 to 85 with mild cognitive impairment or mild Alzheimer's disease. It tests a near-infrared light therapy device against a sham device.

Age
50 to 85 years
Sex
All sexes can join.
Disease stage
Mild cognitive impairment due to Alzheimer's disease, or mild Alzheimer's disease (probable AD dementia), meeting NIA-AA criteria, with a CDR score from 0.5 to 2 and MMSE and ADL-20 limits set by education level.

Main reasons for not taking part

  • Cannot complete blood tests, scale assessments or brain MRI (for example severe vision or hearing problems, severe neuropsychiatric symptoms, MRI contraindications)
  • Other brain injury or disease that caused memory decline (for example severe head injury, severe brain infection, carbon monoxide poisoning, alcohol abuse, primary brain tumor)
  • Unstable or severe heart, lung, liver, kidney or blood disease, or poor general health
  • Large skin lesions or scars on the scalp, or cannot tolerate the heat of the therapy
  • Light sensitivity disorder, or nose problems that prevent using the intranasal device (deviated septum, large polyps, infection, dryness or bleeding)

The registry criteria, word for word

Show all 13 criteriaShow less

Other criteria

  • 1、Inclusion Criteria：
  • Age 50-85 years
  • Meet the 2011 NIA-AA diagnostic criteria for "MCI due to AD" or "probable AD dementia," or meet the 2018 NIA-AA "ATN" diagnostic framework for AD；
  • 0.5 ≤ CDR ≤ 2; for illiterate: MMSE ≤ 13; for primary school education: MMSE ≤ 19; for junior high school or above: MMSE ≤ 24; for MCI: ADL-20 ≤ 22; for mild AD: ADL-20 > 22；
  • Able to understand instructions and cooperate with serological tests, scale assessments, and brain MRI；
  • Have a study partner who can participate throughout the study。; 2、Exclusion Criteria：
  • Inability to complete serological tests, scale assessments, or brain MRI due to severe visual/auditory impairment, severe neuropsychiatric symptoms, contraindications to MRI, etc
  • History of other central nervous system injuries causing cognitive decline (e.g., severe traumatic brain injury, severe CNS infection, carbon monoxide poisoning, alcohol abuse, primary CNS tumors)
  • Unstable or severe heart, lung, liver, kidney, or hematopoietic diseases, poor general health
  • Short life expectancy due to major diseases (e.g., end-stage metastatic cancer cachexia)
  • Large skin lesions or scars on the scalp, or poor heat dissipation that cannot tolerate PBMT
  • Patients with photosensitivity disorders
  • Abnormal nasal structure (deviated septum or large polyps); bacterial or viral infection; nasal dryness/bleeding; nasopharyngeal carcinoma unsuitable for intranasal device insertion

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 50 and 85 years old?

Where in China

  • Department of Cognitive Disorders, Beijing Tiantan Hospital, Capital Medical UniversityBeijing, ChinaContact: Qiwei RenTaking people

About the trial

What the trial wants to find out

The goal of this clinical trial is to learn if photobiomodulation therapy (PBMT) can help treat mild cognitive impairment and mild Alzheimer's disease in adults aged 50 to 85 years. It will also learn about the safety of PBMT. The main questions it aims to answer are:

Read full original descriptionShow less

Does PBMT improve cognitive function in adults with mild cognitive impairment or mild Alzheimer's disease? What medical problems do participants have when using PBMT? Researchers will compare an active PBMT device to a sham (look-alike) device that delivers no active light therapy to see if PBMT improves cognitive function.

Participants will:

Use a transcranial near-infrared light therapy device (or a matching sham device) once a day for 20 minutes, 5 days a week, for 6 months Visit the clinic for cognitive, mood, sleep, and daily-function assessments at the start of the study, at Month 3, and at Month 6 Have brain MRI scans at the start of the study, at Month 3, and at Month 6

The 2 groups in the trial

  • Active PBMTTreatment being tested

    Use the transcranial photobiomodulation device at 810 nm once daily for 20 minutes per session, for 5 consecutive days, followed by 2 days off.

    Treatment: Photobiomodulation

  • Sham PBMTSham treatment, for comparison

    Use the transcranial photobiomodulation device at 660 nm once daily for 20 minutes per session, for 5 consecutive days, followed by 2 days off.

    Treatment: Photobiomodulation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy and Safety of Photobiomodulation Therapy in Patients With Mild Cognitive Impairment and Mild Alzheimer's Disease, A 6-Month, Single-Center, Randomized, Double-Blind, Controlled Trial
Plain-language title
Light therapy for mild cognitive impairment and early Alzheimer's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07835399, who can take part
Record updated
22 September 2026