Intact Cognitive FunctionAICogNCT07766993
Developing and Testing an AI-Based Cognitive Intervention Program
A study testing Lifestyle Intervention in people with Intact Cognitive Function and MCI, run by National Research Center for Rehabilitation Technical Aids.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intact Cognitive Function, MCI, Mild Dementia
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Intact Cognitive Function, MCI, Mild Dementia
- Being tested
- Lifestyle Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
Healthy lifestyle guidance, including diet, cognitive activities, physical activity, social participation, smoking cessation, alcohol abstinence or moderation, sleep management, and stress management.
| Study group | Role | What they receive |
|---|---|---|
| Community Cognitive Cohort | Experimental | AI-Assisted Lifestyle Intervention Cohort Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
Assessed using comprehensive cognitive tests covering multiple domains (orientation, attention, naming, memory, digit span, visuospatial function, and processing speed)
Measured: Baseline to 6 months, and Baseline to 12 months
Secondary outcomes (1)
AD Biomarkers
Blood biomarker testing to assess Alzheimer's disease-related pathological changes (e.g., Change in Plasma p-tau217 Levels)
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intact Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Rehabilitation Technical Aids
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pengxu Wei, National Research Center for Rehabilitation Technical Aids
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766993
- Sponsor's protocol ID
- KY2026-015-01
- Acronym
- AICog
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study involves APOE genetic data and blood biomarker data, which are classified as sensitive personal information and human genetic resources. Sharing such data is subject to stringent ethical reviews and rigorous cross-border data transfer approvals by national human genetic resources regulatory authorities, posing significant operational challenges.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Validation of an Artificial Intelligence-Based Cognitive Intervention Program
- ClinicalTrials.gov ID
- NCT07766993
- Acronym / sponsor ID
- AICog / KY2026-015-01
- Conditions
- Intact Cognitive Function, MCI, Mild Dementia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Research Center for Rehabilitation Technical AidsUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community Cognitive Cohort | Experimental | Behavioral: Lifestyle InterventionAI-Assisted Lifestyle Intervention Cohort |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionHealthy lifestyle guidance, including diet, cognitive activities, physical activity, social participation, smoking cessation, alcohol abstinence or moderation, sleep management, and stress management. | Behavioural | Community Cognitive Cohort |
Primary outcome
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)
1 secondary outcome
AD Biomarkers
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No. This study involves APOE genetic data and blood biomarker data, which are classified as sensitive personal information and human genetic resources. Sharing such data is subject to stringent ethical reviews and rigorous cross-border data transfer approvals by national human genetic resources regulatory authorities, posing significant operational challenges.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Intact Cognitive Function and MCI, run by National Research Center for Rehabilitation Technical Aids.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinxin Wang (+861058122921, ekangfu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: Baseline to 6 months, and Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.