Developing and Testing an AI-Based Cognitive Intervention Program
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorNational Research Center for Rehabilitation Technical Aids
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 ;
Disqualifiers
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);
Trial design
Design model
Single group
Treatments tested in this trial
Lifestyle Intervention
BehavioralHealthy lifestyle guidance, including diet, cognitive activities, physical activity, social participation, smoking cessation, alcohol abstinence or moderation, sleep management, and stress management.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Community Cognitive CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cognitive Function
Assessed using comprehensive cognitive tests covering multiple domains (orientation, attention, naming, memory, digit span, visuospatial function, and processing speed)
Time frame
Baseline to 6 months, and Baseline to 12 monthsSecondary outcomes
1
AD Biomarkers
Blood biomarker testing to assess Alzheimer's disease-related pathological changes (e.g., Change in Plasma p-tau217 Levels)
Time frame
Baseline to 12 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: