NIPH Clinical Trials Search

Primary Recommendation

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Mild Cognitive Impairment (MCI) and Mild Dementia
Date of first enrollment	01/04/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	This study introduces the Egao Note as an extension of routine outpatient care for older adults with Mild Cognitive Impairment (MCI) or mild dementia who are receiving regular outpatient treatment. Participants use the Egao Note in their daily lives for 12 weeks, and the feasibility of implementing this notebook based self management intervention in outpatient settings is evaluated.

Outcome(s)

Primary Outcome

1. Completion rate of the 12 week intervention period The proportion of participants who complete the full 12 week intervention. 2. Continuation rate of Egao Note use The proportion of participants who record in the Egao Note at least once per week during the 12 week intervention period.

Secondary Outcome

1. Acceptability of the intervention At the end of the 12 week intervention, participants evaluate satisfaction, perceived burden, and intention to continue using the Egao Note using a Visual Analog Scale. Mean values and 95 percent confidence intervals are calculated to describe trends in acceptability. 2. Subjective impact based on open ended responses At the end of the intervention, participants complete a brief questionnaire with open ended questions regarding the perceived impact of using the Egao Note on daily life and psychological aspects. Responses are categorized and representative comments are summarized. 3. Operational challenges identified during implementation Throughout the implementation of the intervention as an extension of outpatient care, the principal investigator or co investigators record any challenges or practical issues encountered. These qualitative data are organized to inform improvements for future study design.

Key inclusion & exclusion criteria

Age minimum	>= 65age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Individuals who regularly attend the Department of Neurology at Dokkyo Medical University Nikko Medical Center, or the Miyori Clinic in Nikko City where the same neurologists provide outpatient care. 2. Adults aged 65 years or older at the time of enrollment. 3. Individuals clinically diagnosed with Mild Cognitive Impairment (MCI) or mild dementia by a neurologist. Mild Cognitive Impairment (MCI) is defined as a condition in which activities of daily living (ADL) are generally independent, but objective cognitive decline is observed through neuropsychological assessment, without meeting the diagnostic criteria for dementia. 4. Individuals who receive sufficient explanation about the study from the principal investigator or co-investigators and provide written informed consent.
Exclude criteria	1. Individuals who are clinically judged to have moderate or more advanced dementia and are considered unable to complete the Egao Note or study assessments 2. Individuals with severe physical disability visual impairment motor dysfunction or significant difficulty in writing or reading that makes it difficult to complete study procedures 3. Individuals with severe psychiatric disorders such as schizophrenia or major depressive disorder and are considered unable to participate in the study 4. Individuals who are unlikely to maintain regular outpatient visits during the 12 week intervention period and the pre and post assessments 5. Individuals who are judged by the principal investigator or co investigators to be unsuitable for study participation