NCT07092371 · NOT YET RECRUITING
Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)
The SHINE trial is testing a smartphone app that delivers a multimodal health program — think coordinated lifestyle guidance — to people aged 40 and older who are at high risk for stroke but do not yet have dementia. Researchers will measure cognitive scores and collect brain scans, blood, and stool samples to see whether the app slows cognitive decline. This is a Phase NA randomized controlled trial, meaning it is evaluating real-world effectiveness of a behavioral tool, not a drug.
Eligibility criteria
Inclusion Criteria: * Patients aged ≥ 40 years * High risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack) * Written informed consent available * Primary school education or above * Proficient in using smartphones * Willingness to complete all assessments and participate in follow-up Exclusion Criteria: * previously diagnosed dementia * Suspected dementia after clinical assessment by study physician at screening visit * Previous history of major head trauma and any intracranial surgery * Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions * Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement * Severe loss of vision, hearing, or communicative ability * Patients presenting a malignant disease with life expectancy \< 3 years * Participation in an ongoing investigational drug study Exit Criteria: * Not meet the inclusion criteria * For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator * Any adverse or serious adverse events during the study period judged by Investigator
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-07-29