An interventional study of LLM Conversation Cognitive Interaction and Interest-Based Knowledge Reading in Subjective Cognitive Decline, sponsored by Taipei Medical University Shuang Ho Hospital. Not yet recruiting. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Taipei Medical University Shuang Ho Hospital · Not applicable, Interventional, and Prevention
This study will develop and test a daily conversation platform that uses a large language model, a type of artificial intelligence, to support cognitive health in older adults at high risk of dementia.
The platform will guide participants through voice-based conversations about topics that interest them. The conversations are designed to engage memory, attention, language, planning and problem-solving, and the ability to understand social situations. The platform will also analyze conversation data and create a report describing the participant's cognitive performance.
The study has two stages. In the first stage, 15 participants will test the platform through two 20-minute conversation sessions. This group will include healthy younger adults, older adults with normal cognitive function, and older adults with cognitive difficulties. Participants will provide feedback on how easy and acceptable the platform is to use.
In the second stage, 60 older adults at high risk of dementia will be randomly assigned to one of three groups. The groups will receive either conversation-based cognitive activities using the platform, interest-based news reading activities, or weekly health education while waiting to receive the intervention. The study activities will continue for 12 weeks. Researchers will compare changes in cognitive function, emotional well-being, loneliness, social connection, and user experience before and after the study.
The main goals are to learn whether the platform is practical and acceptable for home use and whether it may help support cognitive and psychosocial health.
Cognitive decline is an important health concern in aging populations. Early cognitive stimulation that is meaningful and related to daily life may help older adults maintain cognitive and psychosocial function. However, many digital cognitive programs use repetitive exercises and provide limited opportunities for natural social interaction.
This study aims to develop and evaluate a large language model-driven daily conversation cognitive interaction platform for older adults at high risk of dementia. The platform uses voice-based, semi-structured conversations based on topics that interest each participant. The conversations are designed to stimulate five cognitive areas: memory, attention, language, executive function, and social cognition.
During each session, participants speak with the platform using natural conversation. The system converts speech into text and analyzes selected features of the participant's responses, such as response accuracy, language fluency, organization of ideas, attention to the conversation, and understanding of social situations. The system then generates a cognitive profile report. This report is intended to provide understandable information about performance across the five cognitive areas and is not intended to diagnose dementia.
The study will be conducted in two stages.
Stage 1 will evaluate the initial feasibility and usability of the platform. Fifteen participants will be enrolled, including five healthy younger adults, five older adults with normal cognitive function, and five older adults with cognitive difficulties. Each participant will complete two 20-minute conversation sessions. Participants will then complete questionnaires about system usability and intervention acceptability. Their comments and experiences will be used to improve the platform before the randomized trial.
Stage 2 will use a single-blind, randomized controlled design. A total of 60 older adults at high risk of dementia will be randomly assigned in equal numbers to one of three groups:
Large language model conversation group: Participants will complete voice-based cognitive conversations with the platform. The activities will include exercises targeting memory, attention, language, executive function, and social cognition.
Interest-based news reading group: Participants will read news content selected according to their interests and complete questions related to the content.
Waitlist control group: Participants will receive weekly health education materials during the initial study period.
The interventions will continue for 12 weeks. Cognitive and psychosocial outcomes will be assessed before and after the intervention. The cognitive assessments will examine overall cognitive function and specific abilities such as memory, attention, language, processing speed, executive function, and social cognition. Psychosocial assessments will examine depressive symptoms, loneliness, and social connection.
The study will also evaluate intervention completion, system usability, and intervention acceptability. The findings will be used to determine whether the platform is feasible for home-based use and whether it shows preliminary benefits for cognitive and psychosocial health in older adults at high risk of dementia.
Taipei Medical University Shuang Ho Hospital is the lead sponsor of 102 studies on the registry; 19 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stage 1: Feasibility Study
Participants must belong to one of the following groups:
Healthy younger adults aged 18 to 40 years. Older adults with normal cognitive function aged 65 years or older and a score of 24 or higher.
Older adults with cognitive impairment aged 65 years or older and a Montreal Cognitive Assessment score of 18 to 23.
Participants must have completed at least elementary school, corresponding to 6 or more years of education.
Participants must be able to read and write Chinese, communicate in Chinese, and understand the study content.
Participants must be able to use a tablet or smartphone independently or with assistance from a family member.
Participants must have sufficient hearing and vision, with usual corrective devices if needed, to complete the study tasks.
Stage 2: Preliminary Efficacy Study
Participants must be aged 65 years or older.
Participants must be considered at high risk of dementia by meeting at least one of the following conditions:
Subjective cognitive decline:
A Subjective Cognitive Decline Questionnaire score greater than 7 out of 24.
A response of yes to both of the following questions:
Compared with your previous usual condition, do you have memory problems? Have your family members or close contacts noticed memory problems compared with your previous condition? Performance within the normal range on standardized cognitive tests, defined as scores no more than 1.5 standard deviations below age- and education-adjusted norms on the Color Trails Test and memory-related assessments.
Mild cognitive impairment:
A diagnosis of mild cognitive impairment made by a neurologist or psychiatrist according to accepted diagnostic criteria.
Evidence of memory performance at least 1.5 standard deviations below age- and education-adjusted normative values on at least one subtest of the Wechsler Memory Scale, Third Edition.
Limited social interaction:
Living alone, living with a person who cannot provide care, or living with a person who is absent for at least 3 days per week; or A score below 12 on the 6-item Lubben Social Network Scale.
A physician diagnosis of hypertension or diabetes for at least 1 year; and A need for ongoing medication or lifestyle management. Participants must have completed at least elementary school, corresponding to 6 or more years of education.
Participants must be able to read and write Chinese, communicate in Chinese, and understand news and study-related content.
Participants must be able to use a tablet or smartphone independently or with assistance from a family member.
Participants must have sufficient hearing and vision, with usual corrective devices if needed, to complete the conversation and reading tasks.
Exclusion Criteria
A diagnosis of dementia or a severe neurodegenerative disorder, such as moderate-to-advanced Parkinson disease or Huntington disease.
A history of a severe psychiatric disorder, such as schizophrenia or severe bipolar disorder, or current acute psychiatric symptoms that may interfere with understanding or responding during conversations.
A major neurological event within the previous 6 months, such as stroke or severe traumatic brain injury, that may substantially affect cognitive or language function.
Severe hearing, speech, or language impairment that prevents basic verbal communication, even when assistive devices are used.
An acute medical illness, active infection, or any condition considered by a physician to make study participation inappropriate.
Inability to complete a 20-minute conversation task or unwillingness to allow collection of interaction data.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will complete a 12-week, home-based cognitive intervention using a large language model-driven conversation platform. They will use the platform five times per week for approximately 20 minutes per session. The platform will begin each session with a brief conversation about the participant's recent experiences. Participants will then select a topic based on their interests and discuss a short topic summary with the platform. The conversations will include activities designed to engage memory, attention, language, executive function, and social cognition. The platform will adjust the depth of questions and follow-up prompts based on the participant's responses. Research staff will provide two initial in-person training sessions and weekly video-call follow-up. Technical support and adherence reminders will be provided through the LINE platform.
Behavioral: LLM Conversation Cognitive Interaction
Participants will complete a 12-week, home-based reading intervention using an interest-based knowledge reading platform. They will use the platform five times per week for approximately 20 minutes per session. During each session, participants will briefly report on their recent experiences and select topics based on their interests. The platform will provide four short news summaries, including familiar and unfamiliar topics and both preferred and non-preferred topics. Participants will answer five multiple-choice questions after each summary to support attention and understanding of the content. Research staff will provide two initial in-person training sessions and weekly video-call follow-up. Technical support and adherence reminders will be provided through the LINE platform.
Behavioral: Interest-Based Knowledge Reading
Participants will receive general health education materials once per week for 12 weeks through the LINE platform. They will not receive the conversation or reading intervention during the initial 12-week study period. After completing the post-intervention assessments, participants will be offered an opportunity to receive one of the two cognitive interventions. Their later intervention assignment will not be included in the primary comparison of the randomized trial.
Behavioral: Waitlist Health Education
A voice-based cognitive stimulation program delivered through a large language model-driven conversational platform. The platform uses topics selected according to each participant's interests and guides natural conversations designed to engage memory, attention, language, executive function, and social cognition. The platform provides topic summaries, asks questions, responds to participants' answers, and adjusts the depth of follow-up questions based on response quality. Conversation responses are converted into text and used to generate indicators of cognitive performance. The platform is intended for cognitive stimulation and does not provide a clinical diagnosis.
A digital cognitive activity that provides short news and knowledge summaries based on participants' interests. The content includes both familiar and unfamiliar topics, as well as preferred and non-preferred topics, to provide varied cognitive challenges. Participants answer multiple-choice questions about each summary. The questions are designed to engage reading comprehension, attention, and memory for the presented information.
General health education materials for older adults delivered through the LINE platform. The materials provide information related to healthy aging and general health management but do not include structured conversational cognitive stimulation or interest-based reading exercises.
Verbal fluency test
The Verbal Fluency Test assesses language production and executive function. Participants will name as many items as possible from specified semantic categories, including fruits and vegetables, within 60 seconds. The outcome is the number of correct, non-repeated words produced. Higher scores indicate better verbal fluency. The primary outcome will be the change in the total number of correct words from baseline to the post-intervention assessment.
Time frame: Change from Baseline at 13 weeks
Chinese Verbal Learning Test
The Chinese Version Verbal Learning Test assesses verbal learning and memory. A list of 9 two-character nouns is presented across 4 learning trials. After each trial, participants recall as many words as possible. One point is given for each correctly recalled word. The total learning score is the sum of correct responses across the 4 learning trials and ranges from 0 to 36. Higher scores indicate better verbal learning. The primary outcome will be the change in the total learning score from baseline to the post-intervention assessment.
Time frame: Change from Baseline at 13 weeks
Digit Span subtest
The Digit Span test assesses verbal attention, short-term memory, and working memory. It includes forward and backward digit span tasks. Each correctly repeated sequence receives 1 point. The forward and backward raw scores are added to produce a total score ranging from 0 to 32. Higher scores indicate better verbal attention and working memory. The outcome will be the change in total score from baseline to the post-intervention assessment.
Time frame: Change from Baseline at 13 weeks
Cookie Theft Picture
The Cookie Theft Picture is a well-known visual stimulus used to assess language comprehension and expressive language abilities. The picture shows a mother washing dishes beside a kitchen sink while the water is overflowing. Two children are standing on a stool and attempting to take cookies from a cupboard. While the participant describes the scene, the assessor evaluates language production, including grammatical structure, word choice, speech fluency, and syntactic errors. The participant is shown the picture and instructed, "Please tell me as completely as possible what is happening in this picture." The task ends when the participant indicates that the description is complete or stops speaking for more than 10 to 15 seconds.
Time frame: Change from Baseline at 13 weeks
Digit Symbol Substitution Test
The Digit Symbol Substitution Test assesses attention and information processing speed. Participants use a key to match numbers with corresponding symbols and complete as many items as possible within 90 seconds. The score is the number of correctly completed items. Higher scores indicate better attention and processing speed. The outcome will be the change in score from baseline to the post-intervention assessment.
Time frame: Change from Baseline at 13 weeks
Stroop Color and Word Test
The Stroop Color and Word Test assesses selective attention and inhibitory control. In the incongruent condition, participants identify the ink color while ignoring the meaning of the printed word. The score is the number of correct responses completed within the specified test period. Higher scores indicate better selective attention and inhibitory control. The outcome will be the change in score from baseline to the post-intervention assessment.
Time frame: Change from Baseline at 13 weeks
Color Trails Test
The Color Trails Test Part 1 assesses visual attention and information processing speed. Participants connect numbered circles from 1 to 25 in ascending order as quickly as possible. The outcome is the completion time measured in seconds. Lower completion times indicate better performance. The outcome will be the change in completion time from baseline to the post-intervention assessment. The Color Trails Test Part 2 assesses complex attention, cognitive flexibility, and executive function. Participants connect numbered circles in ascending order while alternating between 2 colors. The outcome is the completion time measured in seconds. Lower completion times indicate better performance. The outcome will be the change in completion time from baseline to the post-intervention assessment.
Time frame: Change from Baseline at 13 weeks
Theory of Mind Scale
The Theory of Mind Scale assesses the ability to understand other people's thoughts, intentions, and emotions. It includes a verbal task scored from 0 to 30 and a nonverbal picture task scored from 0 to 20. The scores are added to produce a total score ranging from 0 to 50. Higher scores indicate better theory of mind ability. The outcome will be the change in total score from baseline to the post-intervention assessment.
Time frame: Change from Baseline at 13 weeks
Geriatric Depression Scale- 15
The 15-item Geriatric Depression Scale assesses depressive symptoms in older adults. Each item is scored as 0 or 1, producing a total score ranging from 0 to 15. Higher scores indicate more severe depressive symptoms. The outcome will be the change in total score from baseline to the post-intervention assessment.
Time frame: Change from Baseline at 13 weeks
University of California, Los Angeles, Loneliness Scale
The University of California, Los Angeles Loneliness Scale assesses perceived loneliness and social isolation. The scale contains 20 items rated from 1 to 4. Total scores range from 20 to 80. Higher scores indicate greater loneliness. The outcome will be the change in total score from baseline to the post-intervention assessment.
Time frame: Change from Baseline at 13 weeks
Chinese Happiness Inventory
The 10-item Chinese Happiness Inventory assesses subjective happiness and well-being during the previous 3 months. Item scores are added to produce a total score. Higher scores indicate greater subjective happiness and well-being. The outcome will be the change in total score from baseline to the post-intervention assessment.
Time frame: Change from Baseline at 13 weeks
Visual Analogue Scale of Subjective Cognitive Function
Participants rate their perceived cognitive function on a 100-millimeter horizontal visual analogue scale. The left endpoint, 0 millimeters, represents the worst perceived cognitive function, and the right endpoint, 100 millimeters, represents the best perceived cognitive function. The score is the distance in millimeters from the left endpoint to the participant's mark and ranges from 0 to 100. Higher scores indicate better perceived cognitive function. The outcome will be the change in score from baseline to the post-intervention assessment.
Time frame: Change from Baseline at 13 weeks
System Usability Scale
The System Usability Scale assesses participants' perceived usability of the digital intervention. It contains 10 items rated on a 5-point scale. Item scores are converted and multiplied by 2.5 to produce a total score ranging from 0 to 100. Higher scores indicate better perceived usability.
Time frame: Within 1 week after completion of the 12-week intervention (Week 13)
Acceptability of Intervention Measure
The Acceptability of Intervention Measure assesses participants' perceived acceptability of the assigned intervention. It contains 4 items rated on a 5-point scale. The mean of the 4 item scores ranges from 1 to 5. Higher scores indicate greater intervention acceptability.
Time frame: Within 1 week after completion of the 12-week intervention (Week 13)
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Plan to share: No
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Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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