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A clinical trial that investigate the efficacy and safety of transcranial-Photobiomodulation device in Mild Cognitive Impairment due to Alzheimer's Disease

A single-centered, Randomized, Double-blinded, Sham-controlled, Prospective, Confirmatory trial to evaluate the efficacy and safety of transcranial-Photobiomodulation device on cognitive improvement in Mild Cognitive Impairment due to Alzheimer's Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011155
Enrollment
80
Registered
2025-11-12
Start date
2025-05-08
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

None listed

Interventions

Medical Device : Experimental group received a treatment device that exhibited photobiomodulation while the sham group received a device that has idential appearance as the treatment device but exhibi

Sponsors

Y&J Bio Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Those meeting the MCI due to AD guideline as outlined by the NIA-AA Those who are fluent in Korean Those who have agreed to participate in the entire clinical study

Exclusion criteria

Exclusion criteria: Those with CNS disorders other than Alzheimer's that may have caused cognitive impairment Those with structural brain diseases that may have caused cognitive impairment Those with uncontrolled cardiac, renal, and liver function Those who have participated in another clinical trial within 3 months of enrollment Pregnancy or breastfeeding Those whom the investigators deem unsuitable to participate in the clinical trial

Design outcomes

Primary

MeasureTime frame
Korean version of Montreal Cognitive Assessment

Secondary

MeasureTime frame
Korean version of Mini-Mental State Examination

Countries

Korea, Republic of

Contacts

Public ContactSang Soo Ha

St. Peter's Hospital

sshamd@naver.com+82-2-1544-7522

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Apr 24, 2026