Evaluation of the Safety and Efficacy of Non-invasive Phototherapy Targeting Meningeal Lymphatic Vessels in Alzheimer's Disease

Non-invasive Phototherapy Targeting Meningeal Lymphatics in Alzheimer's Disease: A Safety and Efficacy Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500113917

Enrollment

Unknown

Registered

2025-12-04

Start date

2026-01-01

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer disease

Interventions

Alzheimer's Disease group:The intervention consists of photobiomodulation therapy (PBM), administered over a 12-week period, with three sessions per week, each lasting 15 minutes. Transcranial phototh

each site is embedded with an infrared (IR, wavelength 808 nm) LED lamp whose power and frequency parameters are adjustable. The power density during each treatment is 100 mW/cm^2, with a treatment du

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosis of Alzheimer's disease? (clinically probable AD per latest Chinese guidelines + serum p-tau217 confirmation). 2.Aged 18-90 years? at informed consent signing, any gender. 3.MMSE score >10?. 4.Patient fully understands? trial objectives, ?voluntarily signs? informed consent, and ?commits to complete? all trial procedures.

Exclusion criteria

Exclusion criteria: 1.Severe systemic diseases? (e.g., heart failure, respiratory failure, hepatic/renal impairment, immune deficiency, malignancy). 2.Secondary cognitive impairment/dementia? (e.g., thyroid dysfunction, vitamin B12/folate deficiency, autoimmune encephalitis, TBI, epilepsy, cerebral infarction/hemorrhage, alcoholic encephalopathy). 3.Neurodegenerative dementia? (e.g., FTD, DLB, PDD, PSP). 4.MMSE <10?. 5.Investigator-judged ineligibility?. 6.Psychiatric episode/suicidal ideation within 12 months?. 7.PBM-contraindicated factors?: structural brain lesions, epilepsy, photosensitizing drugs (imipramine, St. John's wort, phenothiazines, lithium, chloroquine, hydrochlorothiazide, tetracyclines).

Design outcomes

Primary

Measure	Time frame
DTI-ALPS index on brain MRI;	—

Secondary

Measure	Time frame
ADAS-Cog Scale;ZBI Scale;NPI Scale;Neurodegenerative disease biomarkers (e.g., peripheral blood P-tau217, Aß42/Aß40 ratio, p-tau181, GFAP, and NfL);Eye movement range;	—

Countries

China

Contacts

Public ContactYou Yong

The Second Affiliated Hospital of Hainan Medical University

hy213440@muhn.edu.cn+86 189 7699 1618

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026