cerebral small vessel disease cognitive impairment
Conditions
Interventions
Placebo group :two placebo tablets once a day, folic acid and placebo tablets are produced indistinguishable in terms of size, color, taste, and water dissolution
Folic acid group:two folic acid tablets (0.4 mg/tablet) once a day
Sponsors
Tianjin Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Subjects aged 40-80; (2) Participants with cognitive impairment in memory or other cognitive domains for at least 3 months are diagnosed with mild cognitive impairment (cognitive impairment in one or more cognitive domains is insufficient to affect the independence of life) according to the Chinese Diagnosis and Treatment Guidelines for Cognitive Dysfunction Related to Cerebrovascular Diseases (2019); (3) Montreal Cognitive Assessment (MOCA) score<26 (does not meet the dementia diagnostic criteria of the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders); (4) Head computed tomography or magnetic resonance imaging shows recent subcortical infarctions, lacunar hyperintensities (WMHs), increased perivascular spaces, and microbleeds. According to the Chinese Guidelines for the Diagnosis and Treatment of Cognitive Dysfunction Related to Cerebrovascular Diseases (2019) and the Chinese Consensus on the Diagnosis and Treatment of Cerebrovascular Diseases (2015), there are 2 or more cases of extrabrainstem lacunar infarctions, with a Fazekas score of = 2 and a number of microbleeds = 3; (5) Participants who signed informed consent forms to participate in the trial.
Exclusion criteria
Exclusion criteria: (1) Subjects with intracranial hemorrhage or significant bleeding from other organs; (2) Participants with a history of severe mental illness or epilepsy; (3) Subjects with a history of new stroke within 3 months prior to admission; (4) Participants with a history of alcohol or drug abuse; (5) Participants with Alzheimer's disease, Lewy body dementia, frontotemporal lobe dementia, brain tumors, hydrocephalus, or other central nervous system diseases; (6) Participants who are unable to complete neuropsychological tests and magnetic resonance imaging examinations; (7) Subjects who have participated in clinical trials of other drugs as subjects within the past 30 days; (8) Researchers believe that participants are unlikely to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MoCA score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Folic acid and methionine cycle metabolites;MMSE score;Expression of nitric oxide synthase related genes; | — |
Countries
China
Contacts
Public ContactXumei Zhang
Tianjin Medical University
Outcome results
None listed