VR-based cognitive training for adults with type 2 diabetes and mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label trial compares a virtual reality–based cognitive training system (plus standard diabetes care) to traditional paper-and-pencil cognitive training (plus standard diabetes care) over 24 weeks. Participants are adults aged 45–80 with T2DM and amnestic or mixed MCI, randomly assigned 1:1 to the VR or control arm. The primary outcome is change in MoCA score from baseline to 24 weeks; secondary outcomes include cognitive measures, metabolic parameters, and diabetes self-management metrics. All participants maintain stable glucose-lowering regimens and receive weekly diabetes education. The study also monitors safety and adherence to the VR program in a real-world, clinical setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 45-80 years; gender is not restricted;
2. Participants must meet the diagnostic criteria for diabetes outlined in the \*Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)\*, namely: patients exhibit typical symptoms of diabetes and meet one of the following conditions: 1) HbA1c ≥ 6.5%; 2) Fasting blood glucose ≥7.0 mmol/L. Fasting is defined as no caloric intake for at least 8 hours; 3) 2-hour postprandial blood glucose ≥11.1 mmol/L following an oral glucose tolerance test; 4) Random blood glucose ≥11.1 mmol/L;
3. Stable glycemic control regimen for 3 months or longer;
4. Completed a systematic neuropsychological assessment and meets Petersen criteria for Mild Cognitive Impairment, satisfying the following conditions: 1) The patient or a caregiver subjectively perceives a decline in cognitive function; 2) Assessment results indicate impairment in one or more cognitive domains; 3) There is mild impairment in complex instrumental activities of daily living, but the patient maintains independence in basic activities of daily living; 4) Does not yet meet the diagnostic criteria for dementia;
5. Has an educational level of elementary school or higher and is able to cooperate in completing the assessment, VR training, and various examinations;
6. Cooperate in undergoing magnetic resonance imaging (MRI) examinations;
7. Voluntarily participates in this study, signs an informed consent form, and is able to comply with the study protocol requirements to complete follow-up.

Exclusion Criteria:

1. Suffering from other dementia-related neurological disorders (such as Alzheimer's disease, Parkinson's disease, etc.) or severe mental illness;
2. History of central nervous system disorders, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc.;
3. Severe sinusitis, space-occupying lesions in the nasopharynx, or congenital disorders affecting the sense of smell,or a history of trauma;
4. Glaucoma, severe dry eye syndrome, uncorrected strabismus, severe diabetic retinopathy,or severe motion sickness, making the user unable to tolerate VR devices;
5. History of acute diabetic complications within the past 3 months (diabetic ketoacidosis, hyperglycemic hyperosmolar state, severe hypoglycemia, etc.);
6. Severe impairment of vital organ function, including cardiac, hepatic, or renal dysfunction;
7. Pregnant or breastfeeding women, or women planning to become pregnant during the study;
8. Contraindications for MRI scans, such as the presence of metallic prostheses, pacemakers, cochlear implants, or other metallic implants, or claustrophobia;
9. Participation in other clinical trials currently or within the past 3 months;
10. Known or suspected history of allergy to study-related materials;
11. Currently taking medications intended to improve cognitive function.

Where it's running

• Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yan Bi, MD, PhD
• Email: biyan@nju.edu.cn
• Phone: 6-25-83-105302

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rural Veterans and Care Partners Walking Program

  A virtual walking program is tested to see if it can help Veterans with mild cognitive impairment and their care partners in rural areas walk more each day.

  Recruiting Creighton University · Omaha, Nebraska · NCT07914218

• Lifestyle change program to help type 2 diabetes go into remission in Pakistan

  This study tests whether a structured, plant-predominant lifestyle program can put adults with type 2 diabetes in Lahore, Pakistan into remission for the first six months.

  Recruiting at 2 sites Green International University · Lahore, Punjab Province and 1 other locations · NCT07912944

• China HEAD: a large community study on healthy aging and dementia

  This study tests whether collecting health, imaging, and biospecimen data from adults in China can help predict who will develop Alzheimer’s disease and related dementias.

  Recruiting at 30 sites Fudan University · Beijing and 29 other locations · NCT07912710

• Aging Brain Health Initiative in Fujian

  This observational study will follow about 3,000 older adults in Fujian to see how Alzheimer's-related changes develop and to test new digital tests, biomarkers, and imaging tools for early diagnosis.

  Recruiting at 4 sites Fujian Medical University Union Hospital · Fushun, Fujian and 3 other locations · NCT07891429

• See if multimodal biomarkers can map changes from mild cognitive impairment to dementia

  This observational study tests whether clinical, blood, and brain-imaging markers can tell apart stages of cognitive decline and predict progression from mild cognitive impairment to dementia in about 600 people.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07876570

• LIFU to Help Sleep and Amyloid Reduction in Older Adults with Cognitive Impairment

  A wearable ultrasound device (ATTN201) is being tested to see if it’s safe and easy to use for people 65 and older with mild cognitive impairment and amyloid buildup.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07866768

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.