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CompletedPhase 3

Efficacy and Safety of Tianzhi Granule in Mild to Moderate Vascular Dementia

A Phase III, Multicenter, Randomized, Double-blind, Positive /Placebo Controlled, Parallel, Three Arms Study of Tianzhi Granule in Mild to Moderate Vascular Dementia

Asset

Donepezil

Listed sites

1

Recruiting sites

-

Enrollment

543

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criteria

•Vascular dementia•MMSE 14-26•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•Changes of Clinician's Interview-Based Impression of Change-Plus carer

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

Org study ID2012ZX09104-203
NCT IDNCT02453932

Timeline

Milestones

Study start2013-10 (month precision)
Study first posted2015-05-27estimated
Primary completion2017-05actual (month precision)
Study completion2017-05actual (month precision)
Last update posted2020-01-07actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age45 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Inpatients and outpatients meeting the diagnostic criteria probable VaD established according to the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) （DSM-Ⅳ） and the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN)were eligible to participate,
•diagnosis of mild to moderate vascular dementia;
•Chinese-speaking patients aged ≥45 and≤85 years old in both gender;
•weighing between 45 and 90kg;
•fully conscious;
•MMSE score of≤26 and ≥14;
•HIS score of ≥7;
•adequate vision and hearing ability to complete all study tests;
•with a stable caregiver

Exclusion criteria

Patients will be excluded from the enrollment if they meet any of the followings:

•a medical history of other dementia types, like Alzheimer's disease, Parkinson's disease dementia, Huntington disease, Normal pressure hydrocephalus, et al;
•major depression (HAMD for 17 items>17) or psychotic disorder;
•acute stage of cerebral hemorrhage or subarachnoid hemorrhage;
•hypothyroidism;
•drug or alcohol abuse;
•epilepsy history; myasthenia gravis history;
•severe cardiovascular disease(severe arrhythmia with heart rate≥100 or≤60 times per min, left bundle branch block, myocardial infarction within 3 months, systolic pressure≥180mmHg or ≤90mmHg);
•severe liver or kidney dysfunction (alanine aminotransferase>60 IU/L, aspartate transaminase>60 IU/L or serum creatinine >266μmol/L);
•severe asthma or chronic obstructive pulmonary disease;
•gastrointestinal tract obstruction or severe peptic ulcer; glaucoma;
•administration of cholinesterase inhibitors, memantine or nimodipine in the last month;
•use of sympathomimetic agent, antihistamine drug, antianxiety drugs or tranquilizer within 48h before assessment;
•use of antipsychotic drugs within 72h before assessment;
•participation in other clinical trials; allergic history to any type of medication used in this study.

Endpoints (7)

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

Global cognition
2
Executive function / language
2
Memory
1
Function / daily living
1
Behavior / neuropsychiatric
1

Global cognition

2 endpoints
Primary/protocol endpoint

Changes of Vascular Dementia Assessment Scale-Cognitive Subscale(VADAS-cog) from baseline after 24 weeks' intervention

Time frame:week 0, 4, 12, 24

ADAS-Cog

descriptive

Secondary/protocol endpoint

Changes of Mini-Mental State Examination(MMSE) from baseline after 24 weeks' treatment

Time frame:week 0, 4, 12, 24

Mini-Mental State Examination (MMSE)

descriptive

Memory

1 endpoint
Primary/protocol endpoint

Changes of Clinician's Interview-Based Impression of Change-Plus carer Interview(CIBIC-plus) from baseline after 24 weeks' intervention

Time frame:week 0, 4, 12, 24

change from baseline, improvement

Executive function / language

2 endpoints
Secondary/protocol endpoint

Changes of Clock Drawing Test(CDT) from baseline after 24 week's intervention

Time frame:week 0, 4, 12, 24

descriptive

Secondary/protocol endpoint

Changes of Trail Making Test (TMT) from baseline after 24 week's intervention

Time frame:week 0, 4, 12, 24

descriptive

Function / daily living

1 endpoint
Secondary/protocol endpoint

Changes of Activity of Daily Living Scale(ADL) from baseline after 24 week's intervention

Time frame:week 0, 4, 12, 24

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Changes of Neuropsychiatric Inventory(NPI) from baseline after 24 weeks' intervention

Time frame:week 0, 4, 12, 24

Neuropsychiatric Inventory (NPI)

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.