ClinicalTrials.gg
Not yet recruitingNCT07766993AICogUpdated Aug 18, 2026

Developing and Testing an AI-Based Cognitive Intervention Program

An interventional study of Lifestyle Intervention in Intact Cognitive Function, MCI and Mild Dementia, sponsored by National Research Center for Rehabilitation Technical Aids. Not yet recruiting. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by National Research Center for Rehabilitation Technical Aids · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Intact Cognitive Function
  • MCI
  • Mild Dementia

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03

In context

Dementia

2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 1,758 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

National Research Center for Rehabilitation Technical Aids is the lead sponsor of 6 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 , 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Community Cognitive Cohort

    AI-Assisted Lifestyle Intervention Cohort

    Behavioral: Lifestyle Intervention

Interventions

  • BehavioralLifestyle Intervention

    Healthy lifestyle guidance, including diet, cognitive activities, physical activity, social participation, smoking cessation, alcohol abstinence or moderation, sleep management, and stress management.

06

What researchers measure

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 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)

    Time frame: Baseline to 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.

Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 13 months is below that.

Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 17, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07766993
Lead sponsor
National Research Center for Rehabilitation Technical Aids
Responsible party
Pengxu Wei (director, National Research Center for Rehabilitation Technical Aids) — Principal investigator
First posted
Aug 17, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 18, 2026

Study contacts

Xinxin Wang
Contact
ekangfu@163.com
+861058122921

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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