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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Xinxin Wang
- Telefonnummer: +861058122921
- E-mail: ekangfu@163.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cognitive Function
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
AD Biomarkers
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KY2026-015-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .