Skip to content

Clinical Research of Invisible light stimulation to dementia or mild cognitive impairment patients

A randomized controlled Study on Home-based Interventions of photobiomodulation for Neurocognitive Enhancement in early Alzheimer's Disease.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032230339
Enrollment
30
Registered
2023-09-11
Start date
2024-04-04
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Mild Alzheimers disease and mild cognitive impairment due to Alzheimers disease Alzheimers disease, mild cognitive impairment

Interventions

transcranial near infrared light stimulation

Sponsors

Noda Takamasa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Subjects who are between 60 and 90 years old at the time of obtaining consent (2)Subjects who have a history of hospital visits at the facility where this study is conducted. (3)Subjects diagnosed with early-stage AD (mild AD or MCI due to AD) after a thorough examination at the facility where this study is conducted. (4)Subjects whose MMSE score is between 15 and 30 points. (5)Subjects who have a study partner who lives with the subject or regularly monitors the subject's condition. (6)Subjects or study partners who must be able fill out the online questionnaire and communicate with researchers with emails. (7) Subjects who are on the stable treatment for early-stage AD (drug and non-drug therapy for at least 4 weeks). (8) Subjects who are not expected to have major changes in their circumstances, such as planned adminission to hospitals, long travels, and moving. (9) Subjects who are capable to consent to this clinical research

Exclusion criteria

Exclusion criteria: (1) Subjects whose cognitive decline is judged to be due to causes other than Alzheimer's disease (psychiatric disorders, intellectual disabilities, etc.) (2) Subjects who have not had head imaging (head CT or MRI) performed at the facility where the research is being conducted within the past year, and subjects who are deemed by the study physician to be inappropriate for neuromodulation based on head imaging and/or physical findings. (3) Subjects who are determined to participate in a new clinical trial or clinical research during the period of participation in this study. (4) Subjects whom study physicians deemed inappropriate to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
ADAS-Cog

Secondary

MeasureTime frame
MMSE, CDR, DEMQOL, DEMQOL-Proxy, NPI-Q, ZBI, CGI-I, PGI-I, satisfaction, safety, blindedness

Contacts

Public ContactTakamasa Noda

National Center of Neurology and Psychiatry

t-noda@ncnp.go.jp+81-42-341-2711

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026