Development of non-invasive treatment for MCI by violet light

JRCT ID: jRCTs032210259

Registered date:19/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Amnestic Mild Cognitive Impairment
• Date of first enrollment: 22/03/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Wearing violet light irradiation goggles

Outcome(s)

• Primary Outcome: Safety assessment: treatment-phase adverse events, failures, laboratory tests, electroencephalogram, ophthalmological examinations (visual acuity, intraocular pressure, slit-lamp microscopy, OCT (effects of light stimulation on the retina))

Secondary Outcome

Change from the baseline (pre-observation period) to the 12th treatment week time:
- Cognitive function (MMSE)
- Clinical Dementia Rating (CDR)
- Wechsler memory test (Logical Memory I,II)
- Safety evaluation by ophthalmologic tests (Visual acuity, Intraocular pressure, Slit-lamp microscopy, OCT) to examine the influence of light stimulus to retina

Change from the baseline (before the treatment period) to the 12th treatment week time:
- Paced Auditory Serial Addition Test (PASAT)
- Wechsler memory test (Visual Paired Associates I,II)
- Depression (PHQ-9)
- Anxiety (GAD-7)
- Function Disability (SDISS:Sheehan Disability Scale)
- Well-being (CES-D applicable 4 items)
- Logical memory test (RAVLT)
- Attention / Executive function test (SDMT)
- Sleep (PSQI:Pittsburgh Sleep Quality Index)
- Word Fluency Test (WFT)
- Voice index for cognitive impairment

Adherence check on the use of the device at the end of treatment period

Key inclusion & exclusion criteria

• Age minimum: >= 55age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

> Patients who meet the following definition of NIA-AA and ADNI-II.
- Patients with subjective memory impairment reported by themselves, their family members, or their physicians.
- Patients with memory impairment on the Logical Memory II subscale score modified by educational history on the Wechsler Memory Scale-Revised.
a. 15 points or under for 55 to 64 years old
b. 12 points or under for 65 to 69 years old
c. 11 points or under for 70 to 74 years old
d. 9 points or under for 75 to 79 years old
e. 7 points or under for 80 to 85 years old
Or, regardless of age,
a. 11 points or under for 16 or more years of education
b. 9 point or under for 9-15 years of education
- Patients with a MMSE score of 24 or more and 30 or less at screening
> - Patients with a CDR score 0.5 and a Memory Box score of 0.5 or higher at screening
- Patients whose general cognitive function is preserved to the extent that the physician does not diagnose Alzheimer's disease during screening.
- Patients whose condition is stable for 4 weeks even during drug therapy.In particular, patients whose condition is stable for 12 weeks prior to screening if they are treating with Cholinesterase Inhibitors (ChEIs) or Inhibitory Glutamate Receptors.
> Those who can spend 3 hours with naked eyes, wearing the research device.
> Male or female of 55 to 85 years old
> Those who can agree to participate in this study of one's own will
> Subjects who have been judged by the doctor that a study partner is necessary, must have a study partner. The study partner must satisfy the following conditions. The study partner is physically and mentally healthy, has contact with the subject for more than 7 hours a week, and can accompany all examinations during the observation period, etc.

Exclude criteria

> History of epilepsy or under treatment
> 9 years or less education (Those who have not graduated from primary and secondary schools)
> Patients administered with antidepressants, psychotropic agents and/or hypnotic sedatives including hypnotics (including anti-anxiety agents) taken more than once a week, and whose condition is not stable.
> Complications or history of mental or neurological disorders affecting cognitive function
> Patients with significant central nervous system diseases other than Alzheimer's disease (Parkinson's disease, multiple cerebral infarction vascular type acrophobia, Huntington's disease, normal pressure hydrocephalus, cerebral tumor, progressive supranuclear palsy, etc.)
> Serious complications like liver disorders, renal disorders, endocrine disorders
> Patients with poorly controlled diabetes
> Patients with severe cataract (nuclear sclerosis grade 3 or higher)
> Patients who underwent ophthalmic surgery within 6 months before obtaining consent.
> Patients with retinal abnormalities such as serous retinal detachment and retinal hemorrhage
> Migraine
> Patients whom doctors in charge regard inappropriate for this study

Related Information

• Primary Sponsor: Kitahata Ryosuke
• Source(s) of Monetary Support: Tsubota Laboratory, Inc.