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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT02453932
Eligibility Criteria:
Inclusion Criteria:
* Inpatients and outpatients meeting the diagnostic criteria probable VaD established according to the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) （DSM-Ⅳ） and the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN)were eligible to participate,
* diagnosis of mild to moderate vascular dementia;
* Chinese-speaking patients aged ≥45 and≤85 years old in both gender;
* weighing between 45 and 90kg;
* fully conscious;
* MMSE score of≤26 and ≥14;
* HIS score of ≥7;
* adequate vision and hearing ability to complete all study tests;
* with a stable caregiver.
Exclusion Criteria:
Patients will be excluded from the enrollment if they meet any of the followings:
* a medical history of other dementia types, like Alzheimer's disease, Parkinson's disease dementia, Huntington disease, Normal pressure hydrocephalus, et al;
* major depression (HAMD for 17 items\>17) or psychotic disorder;
* acute stage of cerebral hemorrhage or subarachnoid hemorrhage;
* hypothyroidism;
* drug or alcohol abuse;
* epilepsy history; myasthenia gravis history;
* severe cardiovascular disease(severe arrhythmia with heart rate≥100 or≤60 times per min, left bundle branch block, myocardial infarction within 3 months, systolic pressure≥180mmHg or ≤90mmHg);
* severe liver or kidney dysfunction (alanine aminotransferase\>60 IU/L, aspartate transaminase\>60 IU/L or serum creatinine \>266μmol/L);
* severe asthma or chronic obstructive pulmonary disease;
* gastrointestinal tract obstruction or severe peptic ulcer; glaucoma;
* administration of cholinesterase inhibitors, memantine or nimodipine in the last month;
* use of sympathomimetic agent, antihistamine drug, antianxiety drugs or tranquilizer within 48h before assessment;
* use of antipsychotic drugs within 72h before assessment;
* participation in other clinical trials; allergic history to any type of medication used in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT02453932
Study Brief:
Protocol Section:
NCT02453932