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

NCT02453932 | Completed Phase 3 DMC

• 1 other identifier: 2012ZX09104-203
• Study Type: interventional
• Target: 543
• Locations: 1 country
• Sites: 1

Brief Summary

This ongoing study aimed to evaluate the efficacy and safety of Tianzhi granule in mild to moderate vascular dementia in a more reasonable design.

Conditions

Vascular Dementia

Keywords

Vascular dementia; Tianzhi granule; Herbal medicine; Randomized controlled trial; Three arms

Outcome Measures

Primary Outcomes (2)

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

  Cognition : VaDAS-cog is a revision of the ADAS-cog to be a better measure in vascular conditions. The original ADAS-cog developed by Rosen et al., measures cognitive performance by combining ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. In addition to ADAS-cog, the VaDAS-cog comprises additional frontal lobe tests reflecting attention, working memory, executive function, and verbal fluency.The VADAS-cog will conducted at baseline, 4weeks, 12weeks, 24weeks

  week 0, 4, 12, 24

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

  Overall clinical response: CIBIC-plus is a 7-point scale which provides an index of clinically important change for dementia patients. It is a global measure of detectable change in concentration, orientation, memory, language, behavior, initiative and activities of daily living, usually requiring separate interviews with patients and caregivers,the CIBIC-plus will be conducted at baseline, 4weeks, 12weeks, 24weeks

  week 0, 4, 12, 24

Secondary Outcomes (5)

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

  week 0, 4, 12, 24

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

  week 0, 4, 12, 24

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

  week 0, 4, 12, 24

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

  week 0, 4, 12, 24

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

  week 0, 4, 12, 24

Study Arms (3)

Tianzhi granule

EXPERIMENTAL

Tianzhi granule and placebo identified to donepezil

Drug: Tianzhi granule and placebo identified to donepezil

Donepezil

ACTIVE COMPARATOR

Donepezil and placebo identified to Tianzhi granule

Drug: Donepezil and placebo identified to Tianzhi granule

Placebo

PLACEBO COMPARATOR

Placebo identified toTianzhi granule and placebo identified to donepezil

Drug: Placebo

Interventions

Tianzhi granule and placebo identified to donepezil DRUG

1 pack Tianzhi granule (5g), 3 times per day and placebo identified to donepezil, 1 pill per day for 24 weeks

Tianzhi granule

Donepezil and placebo identified to Tianzhi granule DRUG

donepezil 5mg per day and placebo identified to Tianzhi granule (5g, 3 times per day) for 24 weeks

Donepezil

Placebo DRUG

placebo identified to Tianzhi granule (5g, 3 times per day) and placebo identified to donepezil ,1 pills per day for 24 weeks

Placebo

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100700, China

Location

Related Publications (1)

• Shi J, Wei M, Ni J, Sun F, Sun L, Wang J, Yu T, Wang K, Lv P, Wang Y, Zhang Y, Gao X, Gao X, Luo B, Mao S, Zhang B, Ren X, Yu F, Hu W, Yin P, Wu N, Liu X, Bi Q, Wang Y, Tian J; CHASE Study Group. Tianzhi granule improves cognition and BPSD of vascular dementia: a randomized controlled trial. J Transl Med. 2020 Feb 13;18(1):76. doi: 10.1186/s12967-020-02232-z.

  PMID: 32054507 DERIVED

MeSH Terms

Conditions

Dementia, Vascular

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Jinzhou Tian, MD,PhD

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD，PhD

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 27, 2015
• Study Start: October 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

CN (1)