Developing and Testing an AI-Based Cognitive Intervention Program (AICog)
Research and Validation of an Artificial Intelligence-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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Xinxin Wang
- Numéro de téléphone: +861058122921
- E-mail: ekangfu@163.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Community Cognitive Cohort
AI-Assisted Lifestyle Intervention Cohort
|
Healthy lifestyle guidance, including diet, cognitive activities, physical activity, social participation, smoking cessation, alcohol abstinence or moderation, sleep management, and stress management.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognitive Function
Délai: 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)
|
Baseline to 6 months, and Baseline to 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
AD Biomarkers
Délai: Baseline to 12 months
|
Blood biomarker testing to assess Alzheimer's disease-related pathological changes (e.g., Change in Plasma p-tau217 Levels)
|
Baseline to 12 months
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- KY2026-015-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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