Developing and Testing an AI-Based Cognitive Intervention Program

NCT07766993 | Not Yet Recruiting

• 1 other identifier: KY2026-015-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical study is to learn if an artificial intelligence (AI)-assisted lifestyle intervention program can help protect memory and thinking skills in adults aged 40 years and older who do not have severe cognitive impairment. It will also learn whether the program can help people maintain healthier lifestyle habits and whether it affects blood markers related to Alzheimer's disease. The main questions it aims to answer are: Can the AI-assisted program help participants improve their lifestyle, including diet, exercise, mental activities, social participation, sleep, smoking, alcohol use, and stress? Does a healthier lifestyle help maintain memory and thinking skills over 1 year? Are healthier lifestyle habits related to changes in blood markers such as p-tau217, which may be related to Alzheimer's disease? Does the effect differ for people who carry the APOE ε4 gene, a gene that may increase the risk of Alzheimer's disease? Researchers will compare participants with healthier lifestyles to those with less healthy lifestyles, to see whether healthier lifestyles are linked to better memory and thinking and different blood marker levels. Participants will: Join an online lifestyle intervention program for 1 year. Receive personalized advice about diet, exercise, mental activities, and social participation through an online platform, WeChat tools, an AI assistant, and online messages. Complete memory and thinking tests and lifestyle questionnaires at the start of the study, at 6 months, and at 12 months. Give blood samples at the start of the study and at 12 months for tests related to Alzheimer's disease. Have APOE gene testing at the start of the study.

Conditions

MCI; Mild Dementia; Intact Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Cognitive Function

  Assessed using comprehensive cognitive tests covering multiple domains (orientation, attention, naming, memory, digit span, visuospatial function, and processing speed)

  Baseline to 6 months, and Baseline to 12 months

Secondary Outcomes (1)

• AD Biomarkers

  Baseline to 12 months

Study Arms (1)

Community Cognitive Cohort

EXPERIMENTAL

AI-Assisted Lifestyle Intervention Cohort

Behavioral: Lifestyle Intervention

Interventions

Lifestyle Intervention BEHAVIORAL

Healthy lifestyle guidance, including diet, cognitive activities, physical activity, social participation, smoking cessation, alcohol abstinence or moderation, sleep management, and stress management.

Community Cognitive Cohort

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese community-dwelling residents aged ≥ 40 years;
• Cognitive function adequate to cooperate with testing and interventions;
• No history of major neurological or psychiatric disorders;
• Not on long-term use of medications known to affect cognitive function significantly ;
• Possess the basic access and ability to use smartphones or the internet to receive online interventions;
• Good compliance, with the expected ability to adhere to and complete a 1-year follow-up.

You may not qualify if:

• Age \< 40 years;
• Cognitive function inadequate to cooperate with testing and interventions;
• History of major neurological disorders (e.g., stroke, Parkinson's disease, brain tumors, epilepsy) or severe psychiatric disorders (e.g., schizophrenia, severe depressive episodes);
• Currently taking medications known to significantly affect cognitive function (e.g., anticholinergic drugs, certain psychotropic medications);
• Presence of severe systemic or physical illnesses (e.g., advanced malignancy, severe heart, lung, liver, or kidney failure);
• Lack of access to smartphones or the internet, rendering the participant unable to receive online interventions;
• Any other conditions deemed by the investigator as inappropriate for participation in this study.

Sponsors & Collaborators

• National Research Center for Rehabilitation Technical Aids: lead

Central Study Contacts

Xinxin Wang

CONTACT

+861058122921; ekangfu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share