NCT01160692已完成3 期
A Randomized, Placebo-controlled, Parallel Group, Double Blind Study to Evaluate the Cognitive Effects and Tolerance of a Multi-Vitamin/Mineral Preparation Containing Gingko in Elderly Subjects With Age Associated Memory Impairment
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system.
研究概览
简要总结
A Study to evaluate the cognitive effects and tolerance of a Multi-Vitamin/Mineral Preperation containing Gingko in elderly subjects with age associated memory impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is generally healthy (includes subjects presenting with mild chronic diseases where the disease and/or the pharmacological treatment does not result in psychomotor impairment or improvement).
- •Subject is of either gender, and 60+ years of age, inclusive.
- •Subject demonstrates Age Associated Memory Impairment after completion of the CDR test battery and comparison to normative data.
- •Female subject who is post-menopausal.
- •Subject is able to understand the study instructions and has given written informed consent prior to study participation.
- •Subject admitted to this study is oriented to person, place and time and has the ability to communicate with the study staff.
- •Subject is, in the opinion of the study staff, motivated to participate and complete the study as instructed.
- •Subject is willing to be attend visits in a well-rested state.
排除标准
- •Subject has participated in an interventional study within the one month prior to screening.
- •Intake within three months prior to screening, or intended intake during the study, of one of the following: Ginkgo biloba, St John's Wort, Ginseng, Gotu Kola (Indian Pennywort), or daily doses of vitamin E (-tocopherol) above 30 mg, folic acid above 400 g, vitamins B-1 (thiamine), B-2 (riboflavin), B-6 (pyridoxine) above 2 mg, or other cognition enhancers.
- •Subject has a history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
- •Subject has a history of Alzheimers disease, dementia, mental retardation, Morbus Parkinson, or any other mental disorders.
- •Subject has not been diagnosed with AAMI after completion of the CDR test battery and comparison to normative data.
- •Subject has a history of any bleeding/coagulation disorder (e.g., haemophilia, Protein C or S deficiency).
- •Subject is taking/being treated with a concomitant medication which may affect/inhibit blood coagulation (e.g., warfarin, aspirin, heparin).
- •Subject has history of relevant vascular disorders (e.g., carotid stenosis, stroke, PRIND, coronary artery disease, peripheral vascular disease, thrombosis).
- •Subject has Body Mass Index (BMI) above 40 kg/m2 (severely obese).
- •Subject smokes more than 15 cigarettes, or equivalent daily.
- •Subject has moderate-to-severe hepatic impairment.
- •Subject has history of alcohol or drug abuse.
- •Subject has known allergies or intolerance to any ingredients in the study preparations.
- •Subject is intending to undergo surgery during or immediately upon completion (within two weeks) of study participation.
结局指标
主要结局
The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system.
时间窗: From baseline up to 12 weeks
次要结局
- The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires.(From baseline up to 12 weeks)
- Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko.(From baseline up to 14 weeks)
- The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires.(From baseline up to 12 weeks)
研究者
研究点 (1)
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