Vascular Dementia
Conditions
Interventions
VaD Patient group:none
Normal control group:none
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: VaD Patient Group: According to the VCID diagnostic criteria (AHA/ASA, 2011; VasCog-2-WOS, 2025) and research standards based on screening and diagnostic frameworks for vascular dementia applicable to the Chinese population (2019) and the Chinese vascular cognitive impairment diagnosis and treatment guidelines (2024 edition), the following criteria were formulated: (1) Meet the diagnostic criteria for mild to moderate VaD. Diagnosis: likely vascular dementia. Severity: patients with mild to moderate cognitive impairment (Mini-Mental State Examination score between 10 and 26, and a Global Deterioration Scale score of 1 or 2). (2) Evidence of cerebrovascular disease: medical history, clinical manifestations, and clear cerebrovascular disease evidence on MRI/CT (e.g., multiple infarctions, infarctions in critical areas, lacunar cerebral infarctions, extensive confluent white matter hyperintensities), sufficient to explain the current cognitive impairment. (3) Correlation between dementia and cerebrovascular disease: cognitive impairment occurs within 6 months after a definite stroke and persists for more than 3 months; or sudden cognitive decline, fluctuating, or stepwise cognitive impairment progression. (4) Mini-Mental State Examination (MMSE) score >=10 and =7; (6) No gender restriction, age = 50 years and = 80 years; (7) Adequate vision and hearing to complete neuropsychological testing; (8) Certain level of literacy, previously able to read simple articles and write simple sentences; (9) Have a stable caregiver; (10) Informed consent obtained, signed by the legal guardian. Control Group: (1) No gender restriction, age = 50 years and = 80 years. (2) MMSE scores within the normal range (adjusted for age and education level). (3) No subjective complaints of cognitive decline. (4) Brain MRI shows no or only mild age-appropriate white matter lesions (Fazekas score <=1), no infarctions in critical regions. (5) Informed consent signed by the participant.
Exclusion criteria
Exclusion criteria: VaD Patient Group: (1) Patients already diagnosed with dementia due to other causes, or with supporting imaging or biomarker evidence, such as mixed dementia, Alzheimer's disease, frontotemporal dementia, Parkinson's disease dementia, Lewy body dementia, Huntington's disease, normal pressure hydrocephalus, etc.; (2) Patients with diseases causing cognitive and functional impairment in the brain due to complications such as subdural hematoma, communicating hydrocephalus, brain tumors, thyroid diseases, and vitamin deficiencies; (3) Severe depression (HAMD >=17), severe anxiety (HAMA >=12); (4) Patients with serious neurological dysfunction preventing completion of related tests, such as convenient-hand hemiplegia, various types of aphasia, visual or auditory impairment, etc.; (5) Poorly controlled cardiovascular disease, such as patients with severe arrhythmia who have had a myocardial infarction within 3 months before participating in the trial, or NYHA class 3–4 heart failure, systolic blood pressure =180 mmHg; (6) Severe liver or kidney dysfunction, such as ALT or AST more than 1.5 times the upper limit of normal, or serum creatinine more than 1.0 times the upper limit of normal; (7) Patients with uncontrolled diabetes (HbA1c more than 1.0 times the upper limit of normal); (8) Patients with asthma, chronic obstructive pulmonary disease, multiple neuritis, myasthenia gravis, or muscular atrophy; (9) Patients with severe indigestion, gastrointestinal obstruction, gastric and duodenal ulcers, or other gastrointestinal diseases that may affect drug absorption; (10) Patients with a history of epilepsy, glaucoma, alcoholism, or substance abuse; (11) Patients who have taken cholinesterase inhibitors, memantine, nimodipine, or traditional Chinese cognitive-enhancing drugs within the past month; (12) Patients who have taken sympathomimetic drugs or antihistamines within 48 hours before evaluation that may affect test scores; (13) Patients with allergic constitution or allergy to any component of the trial drug; (14) Patients currently participating in other clinical trials or who have participated in other drug clinical trials within the past month. Control Group: (1) Meet any diagnostic criteria for dementia or mild cognitive impairment. (2) Have severe, acute, or unstable diseases of the heart, brain, liver, kidney, or endocrine system. (3) Have a history of mental illness or alcohol or drug abuse. (4) Have MRI contraindications, such as claustrophobia. (5) Currently receiving any treatment that may affect cognitive function. (6) Currently participating in any clinical trial. (7) Pregnant or breastfeeding women. (8) Unable to communicate with the doctor normally or refuse to sign the informed consent form. (9) Have serious neurological dysfunction preventing completion of related tests, such as convenient-hand hemiplegia, various types of aphasia, visual or auditory impairment, etc.; (10) Have a history of major brain surgery (such as craniotomy) or traumatic brain injury leading to loss of consciousness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Multimodal magnetic resonance imaging; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vascular Dementia Assessment Scale - Cognitive Section (VADAS-cog);Clinical Dementia Rating - Sum of Boxes (CDR-SB);Mini-Mental State Examination (MMSE);Activities of Daily Living (ADL);Delayed Story Recall (DSR);Clock Drawing Test (CDT);Dementia Syndrome Elements Scale (PES-D-11);Hamilton Depression Rating Scale;Hamilton Anxiety Scale;Connection Test Part B;Boston Naming Test;Story Memories - Instant Recall; | — |
Countries
China
Contacts
Public ContactLi Wentao
Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed