Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)

NCT01475578 | Completed Phase 2

• 1 other identifier: 2001ZL272
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

Brief Summary

The objectives of this phase II study of STA-1 capsule was to make preliminary evaluation on clinical efficacy and safety of STA-1 capsule in order that based on the dosage and study structure planned in this project, the dosage and study structure of phase III study can be confirmed.

Conditions

Vascular Dementia

Keywords

Vascular Dementia

Outcome Measures

Primary Outcomes (3)

• Changes from Baseline in Mini-Mental State Examination (MMSE)

  MMSE were used to evaluate subject's change in orientation, attention and calculation, immediate recall and delayed memory, and language ability before and after treatment.

  Month 1, Month 2, , Month 3, , Month 6

• Changes from Baseline in Blessed-Roth Behavior Scale (BBS)

  Month 1, Month 2, , Month 3, , Month 6

• Changes from Baseline in Activities of Daily Living (ADL)

  Month 1, Month 2, , Month 3, , Month 6

Secondary Outcomes (1)

• Changes from Baseline in the symptom scales from Chinese medicine's perspective

  Month 1, Month 2, , Month 3, , Month 6

Study Arms (2)

STA-1

EXPERIMENTAL

STA-1 capsule (Cistanche tubulosa), 2 capsules/time, 3 times/day, orally Dummy Ergoloid Mesylates tablet (Placebo), 2 tablets/time, 3 times/day, orally

Drug: STA-1

Ergoloid Mesylates

ACTIVE COMPARATOR

Ergoloid Mesylates tablet, 2 tablets/time, 3 times/day, orally before meal Dummy STA-1 capsule (Placebo), 2 capsules/time, 3 times/day, orally

Drug: Ergoloid Mesylates tablet

Interventions

STA-1 DRUG

STA-1 capsule (manufactured by Sinphar Tian-Li (Hangzhou) Pharm. Co., Ltd.; Batch number: 020121), 2 capsules/time, 3 times/day, orally

STA-1

Ergoloid Mesylates tablet DRUG

Ergoloid Mesylates tablet (manufactured by Tianjin Huajin Pharmaceutical Factory; Batch number: 011230), 2 tablets/time, 3 times/day, orally before meal

Ergoloid Mesylates

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting criteria of dementia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
• Meeting criteria of vascular dementia according to National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN)
• With Mini-Mental State Examination (MMSE score) ≦17 (illiteracy); ≦20 (elementary school); ≦24 (high school or above)
• With Hachinski's ischemic score (HIS) ≧7
• With marrow-sea deficiency from Chinese medicine's perspective
• Classified mild to moderate dementia based on MMSE score
• With body weight 45 to 95 Kg
• Aged 45 to 80 years old (inclusive). Either gender is eligible. Female subjects must be postmenopausal (for at least 1 year) women without fertility
• Having signed informed consent form
• Correct understanding of pharmaceutical research and good compliance to study personnel's observation and evaluation

You may not qualify if:

• Dementia besides study indication based on DSM-IV and NINDS/AIREN, e.g. Alzheimer's disease, Lwey body disease, etc.
• With HIS \< 7
• Diagnosed significant depression based on DSM-IV with score \>8 or with other mental diseases/disorders
• With cognitive dysfunction caused by head impairment
• With medical history of epilepsy, encephalitis, or any other diseases that may result in dementia, e.g. Parkinson's disease, Huntington disease, Pick disease, etc. Patients with epilepsy attacked occasionally should be examined at the first visit by electroencephalography (EEG) and should be excluded from this study if by the test results are positive.
• With certain diseases that may interfere the evaluation of cognitive function, including abuse of alcohol, or DSM-IV diagnosed abuse of drugs or mental drugs in past 5 years. Severe anemia patients should also be excluded.
• With severe mental dysfunction, e.g. hemiplegia, aphasia, visually and hearing impairment, etc.
• With cardiac disorder, e.g. heart rate ≦ 50 or ≧ 180 times/minute
• With supine or sitting Systolic blood pressure ≦ 100 or ≧ 180 mmHg
• With other disease, especially hepatic, renal, or cardiac disorders, e.g. ALT/SGPT or AST/SGOT \> 3 times of upper limit of normal range, serum creatinine \> 177 umol/L (2mg/dL), or congestive heart failure (cardiac function 2-4 in classification)
• With malignant neoplasm
• With thyroid dysfunction or syphilis
• Failed to control diabetes. Diabetes patients can not enter the study unless the status becomes stable through dietary modification, taking hypoglycemic agents, or receiving insulin.
• With asthma or chronic obstructive pulmonary disease
• With multiple neuritis

Sponsors & Collaborators

• Sinphar Pharmaceutical Co., Ltd: lead

Study Sites (5)

Affiliated Hospital of Chengdu University of Traditional Chinese Medicines, China

Chengdu, China

Location

Fujian Academy of Traditional Chinese Medicine

Fujian, China

Location

Hospital (Traditional Chinese Medicine) Affiliated to Luzhou Medical College

Luzhou, China

Location

Affiliated Hospital of Shaanxi Academy of Traditional Chinese Medicine,

Shaanxi, China

Location

Xi'an Traditional Chinese Medicine Hospital

Xi'an, China

Location

MeSH Terms

Conditions

Dementia, Vascular

Interventions

Ergoloid Mesylates

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)

Dihydroergotoxine; Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mingjun Yang

  Affiliated Hospital of Chengdu University of Traditional Chinese Medicines

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 21, 2011
• Study Start: March 1, 2002
• Primary Completion: October 1, 2002
• Study Completion: October 1, 2002
• Last Updated: November 21, 2011

Record last verified: 2011-11

Locations

CN (5)