Post-stroke cognitive impairment (PSCI)
Conditions
Interventions
Control group:Donepezil + placebo
Investigation treatment group:Donepezil + dL-3-n-Butylphthalide
Sponsors
Affiliated Taihe Hospital of Hubei University of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1)Diagnosed with PSCI according to the guidelines of PSCI management. (2)Acute cerebral infarction with lesion confirmed by MRI and scored 3-18 by NIHSS. (3)Revascularization after artery embolectomy. (4)Aged 50-70 years. (5)Scored 11-26 (or 11-22 for elementary school level) by MMSE evaluation. (6)MoCA evaluation scores 12 years), or <=24 (education with 10-12 years), or <=23 (education with 4-9 years). (7)Enrolled within 2 weeks (<=14 days) after acute cerebral infarction; (8)Received secondary prevention scheme of stroke, including antiplatelet and hypolipidemic agents. (9)Appropriate and agreed to receive monotherapy of donepezil (5mg, qn) to relieve cognitive impairment. (10)Complied with all the study procedures, including treatment schedule, examination plans, and performance scale evaluation. (11)Signed informed consent forms.
Exclusion criteria
Exclusion criteria: (1)Hemorrhagic infarction with hematoncus. (2)With risks of progressing stroke. (3)With a history of cognitive impairment before cerebral infarction. (4)Accompanied by neurologic disorders, including neurodegenerative diseases (e.g. Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia), neuromyelitis optica, epilepsy, central nervous system infection (e.g. AIDS, syphilis), and post-traumatic dementia. (5)Received treatments for cognitive impairment in screening, including cholinesterase inhibitors, memantine, and dL-3-n-Butylphthalide. (6)History of severe depression or mental disorders. (7)Serious allergy history or known allergy to more than 2 kinds of food or medications. (8)Accompanied with one of the following conditions: immunological diseases; autoimmune diseases; allergy diseases; serious cardiovascular, pulmonary, or liver dysfunction. (9)Malignancy history. (10)Uncontrolled serious systemic infection. (11)Serious coagulation disorders. (12)Congenital heart disease. (13)Participation in other clinical trials within 3 months prior to screening. (14)Any other concerns that hampered the compliance or safety as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascular Dementia Assessment Scale-Cognitive (VaDAS-cog) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Barthel Index (BI);EuroQol five dimensions questionnaire (EQ-5D) score;Montreal Cognitive Assessment (MoCA) score;Modified Rankin Scale (mRS) score;National Institute of Health Stroke Scale (NIHSS) score;Beck Depression Inventory-II (BDI-II) score; | — |
Countries
China
Contacts
Public ContactLi Ding
Affiliated Taihe Hospital of Hubei University of Medicine
Outcome results
None listed