JPRN-jRCTs031220615招募中Unknown
The efficacy of ferulic acid and Angelica archangelica extract on patients with mild Alzheimer's dementia: A randomized, double-blind, placebo-controlled study
So Mirai0 个研究点目标入组 320 人开始时间: 2023年2月7日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 320
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
- >= 65age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •(1) Currently attending Tokyo Dental University Ichikawa General Hospital or other hospital
- •(2) Meeting the NIAA diagnostic criteria for probable AD, with the following indications of mild AD:
- •Indications of mild AD
- •1. MMSE-J score of 23 or less
- •2. Clinical Dementia Rating-Japanese (CDR-J) of 0.5 or 1
- •3. Stage 4 (mild) or lower on the Functional Assessment Staging of Alzheimer Disease (FAST)
- •4. Education level of at least 9 years
- •5. Memory criteria: Delayed recall of one paragraph of the Wechsler Memory Scale-Revised Logical Memory II subscale with the cut-off scores according to years of education
- •(3) Taking Donepezil hydrochloride 5mg per day for at least 1 month prior to the start of the study
- •(4) Both subject and legal representative capable of giving informed consent in writing
- •(5) Native Japanese speakers with normal writing ability and no significant audio-visual impairment that would interfere with the evaluation (Abnormalities in writing ability due to neurodegenerative diseases are acceptable)
- •(6) No serious illness or hospitalization interrupting this study
- •(8) No abnormalities in their medical history, physical examination, or general blood test findings that would interfere with the study
- •(9) Attending the study on the designated date with a capability of undergoing the necessary examinations and treatment
排除标准
- •1) Any history of substance-related disorders, such as alcohol or drugs as defined by the DSM-5, within the past 2 years that has affected cognitive function.
- •2) Suffering from depression or bipolar disorder as defined by the DSM-5 within the past year.
- •3) A history of schizophrenia as defined by the DSM-5
- •4) Depressive sate (GDS-S-J score of 11 or higher)
- •5) Huntington's disease, multiple cerebral infarction, normal pressure hydrocephalus, brain tumour, epilepsy, seizure disorder, subdural hematoma, multiple sclerosis, etc.
- •6) Early-onset AD
- •7) Diseases other than AD that affect cognitive function, such as infections or focal lesions such as cortical cerebral infarction
- •8) Vitamin B12 deficiency, syphilis, or abnormalities in thyroid function that affect cognitive function.
- •9) Psychiatric symptoms, excitability, or behavioural abnormalities within the past 3 months that would make it difficult to comply with the research plan.
- •10) Other psychiatric or neurological disorders that would significantly interfere with the performance of this research.
- •11)Serious systemic diseases, severe hepatic disorder, renal disorder, or circulatory disorder.
- •12)Any history of serious food or drug allergies such as anaphylactic shock.
- •13)Currently taking more than 5 mg of donepezil hydrochloride
- •14) Using drugs other than donepezil hydrochloride that affect cognitive function, such as anti-dementia drugs.
- •15) Currently or within the past 6 months participating in any clinical trial of drugs or medical devices, or scheduled to participate in any clinical trial of other Alzheimer's disease drugs during the period of this study
- •16) Taking antipsychotic, antidepressant, or antiepileptic drugs
- •17) Taking anti-anxiety medications for purposes other than sleep treatment.
- •18) Judged by the principal investigator (or co-investigator) to be inappropriate to participate in this study.
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