CTRI/2017/02/007764进行中（未招募）4 期
An Open Label, Multicentre, Phase IV Study to Evaluate the Safety and Treatment Effects of Tebokan® forte (Ginkgo Biloba EGb 761®) One Tablet of 120 mg Twice Daily in Adult Patients with Dementia
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 13
- 主要终点
- Number of presumed adverse drug reactions and percentage of subjects with presumed adverse drug reactions between baseline and week 18
研究概览
简要总结
This is an open label, multicentre, phase IV study to assess the safety and therapeutic effects of Tebokan® forte (Ginkgo biloba dry extract EGb 761®) one tablet of 120 mg administered twice daily in subjects diagnosed with dementia. In this study subjects with at least 50 years of age and diagnosed with dementia in accordance with DSM-5 criteria will be enrolled. During the study a care giver should always accompany with the subject.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Subjects with at least 50 years of age 2 Subjects diagnosed with dementia specifically Major Neurocognitive Disorder due to Alzheimers disease Major Vascular Neurocognitive Disorder or mixed form of both in accordance with DSM 5 criteria cf section 4 1 1 3 MMSE between 12 and 24 inclusive 12 to 18 moderate dementia and 19 to 24 mild dementia 4 Presence of a caregiver 5 Subject LAR ready to give written consent to participate in the trial and ready to follow all study related procedures 6 Post menopausal female subjects or non menopausal female subjects with negative serum pregnancy test and willing to use a reliable means of contraception other than or in addition to hormonal contraceptives eg double barrier method diaphragm plus spermicide condom plus spermicide, etc surgical sterilization or abstinence for the duration of the study.
- •7 Subjects not participating in any other clinical trial since last 6 months.
排除标准
- •Subjects diagnosed with dementia except AD VD or mixed dementia Subjects currently undergoing treatment for depression Subjects with major depression or other psychiatric disorder hospitalized for depression within one year prior to baseline visit Use of Ginkgo biloba within 8 weeks prior to baseline visit Use of cholinesterase inhibitor within 6 months of baseline visit History of any bleeding abnormalities other than in the context of anti platelet or anti coagulant drugs Any other type of neurological disorder as per investigator s discretion Active malignant disease HIV or serious infection as per investigators discretion Subjects currently on cognitive enhancers cholinergic anti cholinergic or haemorheologically active drugs Severe or insufficiently controlled cardiovascular renal or hepatic disorder diabetes anaemia or thyroid dysfunction as per investigator s discretion.
结局指标
主要结局
Number of presumed adverse drug reactions and percentage of subjects with presumed adverse drug reactions between baseline and week 18
时间窗: baseline and week 18
Number of adverse events and percentage of subjects with adverse events between baseline and week 18
时间窗: baseline and week 18
Number of serious adverse events and percentage of subjects with serious adverse events between baseline and week 18
时间窗: baseline and week 18
Changes in the vital signs physical and laboratory examination between baseline and week 18
时间窗: baseline and week 18
次要结局
- Change from baseline to week 18 in a picture learning test representing attention and memory CERAD constructional praxis and recall of constructional praxis(baseline and week 18)
- Change from baseline to week 18 in the Trail Making Test A and B representing speed and executive functioning(baseline and week 18)
- Number and percentage of patients with improvement in cognitive functioning from baseline to week 18 for Trail Making Test and CERAD constructional praxis and recall of constructional praxis either or both(baseline and week 18)
- Change from baseline to week 18 in the BEHAVE AD(baseline and week 18)
- Change in CGI scale from baseline to week 18(baseline and week 18)
- Number and percentage of subjects improving or recovering from vertigo and or tinnitus from baseline through week 18 via 11 Point Box Scales for vertigo and tinnitus(baseline and week 18)
研究者
研究点 (13)
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