Efficacy and safety of butylphthalide on patients with mild cognitive impairment

Conditions

Alzheimer's disease

Shan A, Xu C, Chen R, Han X, Sun W, Yao Q, Wang X, Luan H, Li S, Wen B, Cui T, Guo J, Lian Q, Sun Y, Li C, Jia H, Ma H, Lv S, Sun Q, Wei C.

2026-04-23

10.1177/13872877261443718

Structural and metabolic topological alterations associated with butylphthalide treatment in mild cognitive impairment: Data from a randomized, double‐blind, placebo‐controlled trial

Xiaodong Han, Shuting Gong, Jin Gong, Pei Wang, Ruina Li et al. (16 authors)

Psychiatry and Clinical Neurosciences2025-03-311 citations

10.1111/pcn.13812

Efficacy and safety of butylphthalide in patients with mild cognitive impairment: a multicentre, randomised, double-blind, placebo-controlled trial (EBMCI study)

Pei Wang, Wenxian Sun, Jin Gong, Xiaodong Han, Chang Xu et al. (13 authors)

BMJ Open2024-07-018 citations

10.1136/bmjopen-2023-082404

Interventions

experimental group:Butylphthalide Soft Capsules

control group:placebo-controlled drugs

Eligibility

Sex/Gender

All

Age

50 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Inpatient or outpatients of male or female MCI patients aged 50-85 years; (2) MMSE 20-26 points (including 20 points and 26 points), CDR score = 0.5 points; (3) Be able to communicate in Chinese; (4) An informed consent is required.

Exclusion criteria

Exclusion criteria: (1) Diagnosed as dementia after baseline investigation; (2) There is a clear history of cerebrovascular stroke, and there are clear signs or symptoms of neurological deficits at the time of onset, and the corresponding neurological images have corresponding responsible lesions; (3) Severe white matter lesions, Fazekas score = 3 points; (4) Suffering from any cause causing disturbance of consciousness; (5) A serious aphasia or physical disability cannot complete the neuropsychological examination; (6) Now suffering from related depression (Hamilton Depression Scale score > 8 points) or mentally ill; (7) A history of alcoholism, or a history of drug addiction, or a brain injury such as brain trauma, epilepsy, encephalitis, normal intracranial pressure hydrocephalus, etc., which can cause cognitive impairment; (8) Suffering from systemic diseases (such as liver and kidney dysfunction, endocrine diseases, vitamin deficiency) that may cause mild cognitive impairment; (9) Allergic to celery; (10) Those who are participating in other drug clinical research.

Design outcomes

Secondary

Measure	Time frame
MMSE;CDR;NPI;Immediate memory;Delayed recall;digit span;trail making test;ADL;FDG-PET;	—

Primary

Measure	Time frame
ADAS-Cog;	—

Countries

China

Contacts

Public ContactCuibai Wei

Xuanwu Hospital, Capital Medical University

chuibainews@126.com+86 13910076457

Outcome results

None listed