JPRN-jRCT1091220187已完成1 期
Efficacy and safety of ferulic acid and Angelica archangelica extrac in patients with mild cognitive impairment (MCI): Double blind placebo-controlled study - FAMCIS
Hokuriku National Hospital0 个研究点目标入组 20 人开始时间: 2014年7月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 60age old 至 ot applicable(—)
- 性别
- All
入选标准
- •1.MCI outpatients older than 60 years old at informed consent.
- •2.Patients with MCI who fulfilled the MCI criteria (Reisberg(1991); MayoClinic,Petersen(1995)).
- •3.MMSE score 20-26 points and CDR score 0.5 or 1.
- •4.Patient could be distinguished from other dementia disorders.
- •5.Patient can administrate the tablets and patient and patient's family can manage taking medicine.
- •6.Written informed consent of patient and patient's family.
排除标准
- •1.Patients taken supplements which contain polyphenols within 1 month.
- •2.Patients with severe heart disease, liver disease, kidney disease.
- •3.Patients who has malignancy.
- •4.Patients who has previous history of alcohol and/or drug abuse.
- •5.Patients who has hypersensitivity to polyphenols.
- •6.Patients who has drug and/or food allergy.
- •7.Patients participating in other clinical trials.
- •8.Patients newly administrated other dementia therapeutics within 30 days including Galantamine Hydromide (Reminyl, Takeda pharmaceutical company limited. Janssen pharmaceutica), Memantine Hydrochoride (Memary, DaiichiSankyo company limited), Rivastigmine (Exelon patch, Novartis/ Rivastach patch, Ono pharmaceutical company limited), Donepezil Hydrochloride (Aricept, Aricept D, Eisai). During this trial, addition and change of other dementia therapeutic drugs are not permitted in principle.
- •9.The patients judged to inadequacy by the attending physician or principal investigator.
研究者
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