Developing and Testing an AI-Based Cognitive Intervention Program

N/ANot Yet RecruitingNCT07766993

National Research Center for Rehabilitation Technical Aids100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Chinese community-dwelling residents aged ≥ 40 years; 2. Cognitive function adequate to cooperate with testing and interventions; 3. No history of major neurological or psychiatric disorders; 4. Not on long-term use of medications known to affect cognitive function significantly ; 5. Possess the basic access and ability to use smartphones or the internet to receive online interventions; 6. Good compliance, with the expected ability to adhere to and complete a 1-year follow-up. Exclusion Criteria: 1. Age \< 40 years; 2. Cognitive function inadequate to cooperate with testing and interventions; 3. History of major neurological disorders (e.g., stroke, Parkinson's disease, brain tumors, epilepsy) or severe psychiatric disorders (e.g., schizophrenia, severe depressive episodes); 4. Currently taking medications known to significantly affect cognitive function (e.g., anticholinergic drugs, certain psychotropic medications); 5. Presence of severe systemic or physical illnesses (e.g., advanced malignancy, severe heart, lung, liver, or kidney failure); 6. Lack of access to smartphones or the internet, rendering the participant unable to receive online interventions; 7. Any other conditions deemed by the investigator as inappropriate for participation in this study.

Outcomes

Primary Outcomes

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 months

Secondary Outcomes

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 months

Developing and Testing an AI-Based Cognitive Intervention Program

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts