The Efficacy of Butylphthalide Soft Capsules in Patents With VCIND

Phase 2/3 Unknown 200 enrolled The Second Hospital of Hebei Medical University

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start: 2017-01
Primary completion: 2019-01
Completion: 2019-07

Outcome

Met primary endpoint

paper NBP showed greater effects than placebo on ADAS-cog (NBP change -2.46 vs. placebo -1.39; P = .03; ITT) PMID 26086183 ↗

paper CIBIC-plus (80 [57.1%] vs. 59 [42.1%] patients improved; P = .01; ITT). PMID 26086183 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Butylphthalide	Small molecule	200 mg	Oral