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

JRCT ID: jRCTs032230339

Registered date:11/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mild Alzheimer's disease and mild cognitive impairment due to Alzheimer's disease
• Date of first enrollment: 11/09/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): transcranial near infrared light stimulation

Outcome(s)

• Primary Outcome: ADAS-Cog
• Secondary Outcome: MMSE, CDR, DEMQOL, DEMQOL-Proxy, NPI-Q, ZBI, CGI-I, PGI-I, satisfaction, safety, blindedness

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 90age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Inagawa Takuma
• Source(s) of Monetary Support: Japan Society for the Promotion of Science