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

• Status: Completed
• Trial end date: 2002-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sinphar Pharmaceutical Co., Ltd
• Treatments: Dihydroergotoxine; Ergoloid Mesylates

Criteria

Inclusion Criteria:

1. Meeting criteria of dementia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)

2. 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)

3. With Mini-Mental State Examination (MMSE score) ≦17 (illiteracy); ≦20 (elementary school); ≦24 (high school or above)

4. With Hachinski's ischemic score (HIS) ≧7

5. With marrow-sea deficiency from Chinese medicine's perspective

6. Classified mild to moderate dementia based on MMSE score

7. With body weight 45 to 95 Kg

8. Aged 45 to 80 years old (inclusive). Either gender is eligible. Female subjects must be postmenopausal (for at least 1 year) women without fertility

9. Having signed informed consent form

10. Correct understanding of pharmaceutical research and good compliance to study personnel's observation and evaluation

Exclusion Criteria:

1. Dementia besides study indication based on DSM-IV and NINDS/AIREN, e.g. Alzheimer's disease, Lwey body disease, etc.

2. With HIS < 7

3. Diagnosed significant depression based on DSM-IV with score >8 or with other mental diseases/disorders

4. With cognitive dysfunction caused by head impairment

5. 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.

6. 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.

7. With severe mental dysfunction, e.g. hemiplegia, aphasia, visually and hearing impairment, etc.

8. With cardiac disorder, e.g. heart rate ≦ 50 or ≧ 180 times/minute

9. With supine or sitting Systolic blood pressure ≦ 100 or ≧ 180 mmHg

10. 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)

11. With malignant neoplasm

12. With thyroid dysfunction or syphilis

13. 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.

14. With asthma or chronic obstructive pulmonary disease

15. With multiple neuritis

16. With myasthenia gravis and amyotrophic

17. With severe indigestion, or gastrointestinal obstruction, or gastric and duodenal ulcer, or other gastrointestinal diseases that can affect drug absorption

18. With glaucoma

19. Ever attending other clinical trials in past 30 days