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Vascular cognitive impairment no dementia (VCIND) is very common among the aged and tends to progress to dementia, but there have been no proper large-scale intervention trials dedicated to it. VCIND caused by subcortical ischemic small vessel disease (hereinafter, subcortical VCIND) represents a relatively homogeneous disease process and is a suitable target for therapeutic trials investigating VCIND. Preclinical trials showed that Butylphthalide Soft Capsules is effective for cognitive impairment of vascular origin. In this randomized, double-blind, placebo-controlled trial, the investigators apply fMRI study the effects of Butylphthalide Soft Capsules in patients with VCIND.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the Butylphthalide Soft Capsules group | Experimental | 600mg Butylphthalide Soft Capsules/day,po tid,period of 6 months |
|
| the placebo group | Placebo Comparator | 60mg Butylphthalide Soft Capsules/day,po tid,period of 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butylphthalide Soft Capsules | Drug | DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.Butylphthalide Soft Capsules is the oral preparation. |
| Measure | Description | Time Frame |
|---|---|---|
| change of Cognitive function | Time points 0, 1, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change of brain function | Time point at 0, 1, 3, 6 months |
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Inclusion Criteria:
Literate Han Chinese aged from 40 to 65 years
MMSE ≥24
Normal or slightly impaired activities of daily living
The MRI entry criteria are as follows:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifei Zhu, M.D. | Contact | +8613303046666 | 13831155688@163.com | |
| Panpan Liang, M.D. | Contact | +8617717711528 | 2354672781@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yifei Zhu, M.D. | The Second Hospital of Hebei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Hebei medical university | Recruiting | Shijiazhuang | Hebei | 050000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26086183 | Result | Jia J, Wei C, Liang J, Zhou A, Zuo X, Song H, Wu L, Chen X, Chen S, Zhang J, Wu J, Wang K, Chu L, Peng D, Lv P, Guo H, Niu X, Chen Y, Dong W, Han X, Fang B, Peng M, Li D, Jia Q, Huang L. The effects of DL-3-n-butylphthalide in patients with vascular cognitive impairment without dementia caused by subcortical ischemic small vessel disease: A multicentre, randomized, double-blind, placebo-controlled trial. Alzheimers Dement. 2016 Feb;12(2):89-99. doi: 10.1016/j.jalz.2015.04.010. Epub 2015 Jun 15. |
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| Placebo Butylphthalide Soft Capsules | Drug |
|