UnknownPhase NA

The Efficacy of DL-NBP in Patients With Mild Subcortical Ischemic Vascular Dementia

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

Lead sponsor

Tianjin Medical University General Hospital

Asset

Butylphthalide

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Vascular cognitive impairment / dementia

Key I/E criteria

•MMSE 15•MoCA ≤26•Study partner/caregiver required

Primary endpoints

•Auditory Verbal Learning Test (AVLT) at endpoint and change•Brief Visuospatial Memory Test-Revised (BVMT-R) at endpoint and change•Digital span (DS) at endpoint and change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03906123

Org study IDTianjinMUGH001

Timeline

Milestones

Study start2017-11-18actual

Study first posted2019-04-08actual

Last update posted2019-04-08actual

Primary completion2019-12-31estimated

Study completion2020-01-31estimated

Assets

Drug assets

Butylphthalide

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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 50-80 years, years of education no less than 3, an MMSE range of 15~26, an MoCA < 26, an Hamilton Depression Scale (HAMD) < 17;

3. The MRI (one research dedicated machine 3.0 T) features satisfy subcortical small vessel disease, including (1) multiple (>=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

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

Endpoints (23)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Executive function / language

Neuroimaging

Global cognition

Behavior / neuropsychiatric

Memory

Other (unclassified)

Function / daily living