Developing and Testing an AI-Based Cognitive Intervention Program

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.

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Key information

Conditions

Intact Cognitive Function MCI Mild Dementia

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

Cognitive Function

Time frame: Baseline to 6 months, and Baseline to 12 months

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

Secondary outcomes

AD Biomarkers

Time frame: Baseline to 12 months

Blood biomarker testing to assess Alzheimer's disease-related pathological changes (e.g., Change in Plasma p-tau217 Levels)

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

National Research Center for Rehabilitation Technical Aids

Other

Registry information

Official study title

Research and Validation of an Artificial Intelligence-Based Cognitive Intervention Program

Acronym: AICog

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 17, 2026
Registry last updated: Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed