A randomized, double-blind, placebo controlled study on the efficacy of Butylohthalide in patients with mild subcortical ischemic vascular dementia

The Efficacy of DL-3-n-butylphthalide on the Cognitive Function and Vascular Regulation in Patients With Mild Vascular Dementia Caused by Subcortical Ischemic Vascular Disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-17013143

Enrollment

Unknown

Registered

2017-10-28

Start date

2017-11-01

Completion date

Unknown

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild subcortical ischemic vascular dementia

Interventions

experimental group:Butylohthalide

control group:placebo

Eligibility

Sex/Gender

All

Age

50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients meet the criteria of major neurocognitive disorder in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 2. Patients aged with 50-85 years, years of education no less than 3, an MMSE range of 15~26, an MoCA =3) supratentorial subcortical lacunes (3–20 mm in diameter), with/without white matter hyperintensities (WMH) of any degree; (2) moderate to severe WMH (score>= 2 according to the Fazekas rating scale in either periventricular region or deep white matter) with/without lacunes; (3) one or more strategically located subcortical small infarcts in the deep grey matters; 4. Patients or legal representative should sign the informed consent and have a reliable caregiver.

Exclusion criteria

Exclusion criteria: 1. Cognitive impairment caused by other central nervous system diseases, such as AD, dementia with Lewy body, frontal-temporal lobe degeneration, etc.; 2. Cognitive impairment due to other conditions, such as severe depression, vitamin B 12 deficiency, abnormal thyroid function, etc.; 3. Alcoholism, drug abuse or other conditions influenced the evaluation of cognition; 4. Patients unable to undertake MRI assessment. 5. Patients with a history of other severe disease such as epilepsy, myocardial infarction or heart failure will be excluded; 6. Administration of other investigational drugs, psychotropic drugs, drugs with psychiatric side effects, and oral anticoagulants are not allowed.

Design outcomes

Primary

Measure	Time frame
AVLT;BVMT-R;SDMT;TMT A/B;BNT;COWAT;DS;Stroop;Verbal fluency test;MMSE;MoCA;ADL;	—

Secondary

Measure	Time frame
CDR;NPI;	—

Countries

China

Contacts

Public ContactZhang Nan

Tianjin Medical University General Hospital

nanzhang@tmu.edu.cn+86 13752128310

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026