Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT07081750
Eligibility Criteria:
Inclusion Criteria:
Patients:
* Aged ≥60 years;
* ICD-10 diagnosed dementia with Clinician's Dementia Rating (CDR) scores of 1-2 (mild-to-moderate stage);
* Preserved basic verbal communication capacity;
* Exhibit at least one neuropsychiatric symptom (score ≥1 on any item) in the past month, as assessed by the Neuropsychiatric Inventory (NPI);
* Medically cleared for discharge with planned home-based care;
* Willing to provide written informed consent.
Caregivers:
* Aged ≥18 years;
* Designated primary caregiver (the individual spends the longest time caring for the patient each day);
* Committed to maintaining home caregiving responsibilities for at least 3 months post-discharge;
* Intact verbal communication skills;
* Possess basic operational proficiency with the WeChat application (capable of independently sending/receiving messages and conducting voice/video calls)
* Willing to provide written informed consent.
Exclusion Criteria:
Patients:
* Comorbid severe somatic diseases (e.g., malignant tumors, heart failure, physical disabilities) or psychiatric disorders;
* Severe visual or hearing impairment;
* Dementia caused by the following conditions: Central nervous system diseases (e.g., encephalitis, brain tumors, epilepsy, multiple sclerosis, Parkinson's disease); Nutritional/metabolic disorders (e.g., thyroid dysfunction, vitamin B12/folate deficiency); Substance or alcohol dependence; Other potential etiologies of secondary dementia;
* Severe physical or mental illness, extreme debilitation, long-term bedridden status, end-stage disease (with a life expectancy of less than six months), or an inability to cooperate with or tolerate the study;
* Currently participating in other medical research that may interfere with study outcomes.
Caregivers:
* Comorbid severe somatic diseases (e.g., malignant tumors, heart failure, physical disabilities) or psychiatric disorders;
* Severe visual or hearing impairment;
* Currently participating in other medical research that may interfere with study outcomes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT07081750
Study Brief:
Protocol Section:
NCT07081750