The Effects of Omega-3 Fatty Acids Monotherapy in Alzheimer's Disease and Mild Cognitive Impairment: a Preliminary Randomized Double-Blind Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus)
研究概览
简要总结
This preliminary study is aimed to investigate whether it is feasible to conduct a study to use fish oil compared to the placebo(olive oil) in people with cognitive impairment. We will also explore whether fish oil has better efficacy in some clinical aspects in people with cognitive impairment during 24 weeks intervention. The major clinical outcome will be:
- general clinical impression
- cognitive function
详细描述
Despite some positive findings from observational and animal studies, the effects of n-3 PUFA administration on cognitive impairment in humans have received little evaluation to date. Although some clinical trials of fish oil have been reported, the results are inconsistent. Given these inconsistent findings, we carried out a preliminary study to investigate the effect of fish oil monotherapy on cognitive function and general clinical condition in patients with cognitive 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
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fulfilled the diagnosis of AD according to the American Psychiatric Association, DSM-IV criteria, with mild or moderate severity( defined by an Mini Mental Status Examination (MMSE) score between 10 and 26, and a Clinical Dementia Rating (CDR) score of 1 or 2.)
- •or amnesic MCI( defined as (1). Subjective memory impairment by the patient and /or an informant, (2) objective memory impairment falling at least 1.5 standard deviations or more below age- and education-specific norms on the Logical Memory delayed-recall score from the Wechsler Memory Scale III (3) relatively normal performance in other cognitive domains, (4) no impairment in activities of daily living, and (5) failure to meet DSM-IV criteria for dementia.)
排除标准
- •inadequate motor or sensory capacity to comply with testing
- •any ischemic lesion on brain CT reported by the radiologist or a modified Hachinski Ischemic Scale score >4
- •a 17-item Hamilton Depression Scale (HDRS)score > 13
- •abnormal levels of folic acid, vitamin B12, or thyroid function
- •severe comorbidity, including another neurodegenerative diseases, another chronic debilitating neurological illness (e.g. cerebral palsy), brain trauma, tumors, severe pulmonary, renal, liver disease, cardiac disease, or autoimmune disease, or conditions expected to cause death within one year.
- •Participants with a diagnosis of alcoholism, schizophrenia, and bipolar disorder were excluded.
- •Participants receiving cholinesterase agents during the screen or taking NSAID on a long-term basis
结局指标
主要结局
the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus)
时间窗: 24 weeks
the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog)
时间窗: 24 weeks
次要结局
- Mini Mental Status Examination (MMSE) scores(24 weeks)
- 17-item Hamilton Depression Scale (HDRS)(24 weeks)
- adverse events(24 weeks)