Vascular Cognitive Impairment
Conditions
Interventions
A Group:Oral donepezil hydrochloride tablets (Dosage: 5 mg once daily Duration: 12 weeks)
C Group:Donepezil hydrochloride tablets (same as Group A) PLUS Sham electroacupuncture (Location: Non-acupoints 2cm lateral to true acupoints
Stimulation: No electrical current delivered
Session match: Identical duration/frequency to active EA)
B Group:Donepezil hydrochloride tablets (same as Group A) PLUS Electroacupuncture treatment((Acupoints: DU20 (Baihui) GV24 (Shenting) ST36 (Zusanli) and RN12(Zhongwan)
Parameters: 2/100 Hz dense-disperse waves 30 min/session
Frequency: 2 sessions/week for 12 weeks))
Sponsors
Weifang Hospital Of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients meeting ALL of the following 7 criteria will be enrolled: Meet the aforementioned diagnostic criteria for Vascular Cognitive Impairment (VCI) Aged 45-80 years either sex Females must be surgically sterile or postmenopausal (non-childbearing potential) Rated as having mild to moderate impairment on the Clinical Dementia Rating (CDR) scale (CDR global score = 0.5 or 1) Hachinski Ischemic Scale (HIS) score = 7 points Cornell Scale for Depression in Dementia (CSDD) score < 8 points Mini-Mental State Examination (MMSE) score meeting education-adjusted thresholds: Illiterate: = 17 points Elementary education: = 20 points Junior high school or higher: = 24 points Capable of understanding the study procedures voluntarily participating and providing written informed consent
Exclusion criteria
Exclusion criteria: Patients meeting ANY of the following criteria will be excluded: Definitively diagnosed with other types of dementia e.g. Alzheimer's disease Dementia with Lewy Bodies (DLB) OR exhibiting features of progressive neurodegenerative cognitive disorders Cognitive decline attributable to other causes including: Severe metabolic disorders (e.g. untreated hypothyroidism hepatic encephalopathy) Endocrine diseases (e.g. Cushing's syndrome uncontrolled diabetes mellitus) Comorbid major depressive disorder (MDD) or severe psychiatric conditions: *Major Depressive Disorder (severe episode per DSM-5 criteria)* Schizophrenia Bipolar Disorder or other psychotic disorders History of psychiatric hospitalization within 6 months that may confound cognitive assessments Neurological disorders potentially affecting cognition: Parkinson's disease Huntington's disease Brain tumors encephalitis multiple sclerosis or other significant CNS diseases Severe systemic organ dysfunction: *NYHA Class III/IV heart failure COPD GOLD Stage 3/4* *Child-Pugh Class B/C liver cirrhosis CKD Stage 4/5 (eGFR 1.5 platelets <50×10?/L)* Current anticoagulant/antiplatelet therapy (e.g. warfarin clopidogrel) Hematological disorders increasing bleeding risk (e.g. hemophilia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mild Behavioral Impairment Checklist;Mini-Mental State Examination;Auditory Verbal Learning Test;Cognitive Decline Complaints Scale;Instrumental Activities of Daily Living Scale; | — |
Countries
China
Contacts
Public ContactDong Han
Weifang Hospital Of Traditional Chinese Medicine
Outcome results
None listed