NCT00437983已完成4 期
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
Enzymotec2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2007年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Change From Baseline in Rey Auditory Verbal Learning Test
研究概览
简要总结
The primary objective of this trial is to assess the ability of an oral administration of Phosphatidylserine-Omega3 to improve attention and memory complaints in comparison to placebo in age associated memory impaired subjects.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to give written informed consent
- •Age: 90≥ years ≥50
- •Gender: male and female
- •Complaints of memory loss reflected in such everyday problems as difficulty remembering names of individuals following introduction, misplacing objects, difficulty remembering multiple items to be purchased or multiple tasks to be performed, difficulty remembering telephone numbers or zip codes, and difficulty recalling information quickly or following distraction. Onset of memory loss must be described as gradual, without sudden worsening in recent months. Complaints of memory loss to be assessed by the MAC-Q scale.
- •Mini-Mental State Examination (MMSE) ≥27 for subjects with college education (BA) and ≥ 26 for all others
- •Memory test performance that is at least 1 SD below the mean established for young adults on at least one neuropsychological subtest of NexAde.
- •Language: Subjects must be able to read, write and speak Hebrew.
- •Ability to perform tests and interviews
排除标准
- •Evidence of delirium, confusion, or other disturbances of consciousness
- •Any Neurological disorder that could produce cognitive deterioration. Such disorders include AD, Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors, and normal pressure hydrocephalus
- •History of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies
- •Evidence of significant cerebral vascular pathology
- •Head injury immediately preceding cognitive deterioration.
- •Current psychiatric diagnosis according to DSM IV criteria of depression, mania, or any other major psychiatric disorder
- •Current diagnosis or history of alcoholism or drug dependence.
- •Evidence of depression as determined by the Geriatric Depression Scale (short version) score of 5 or more.
- •Any medical disorder that could produce cognitive deterioration including renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances unless well controlled, and malignancy not in remission for more than two years
- •Use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing.
- •Use of any experimental medication within 1 month prior to screening or as concomitant medications.
- •Subject has a history of hypersensitivity or allergy to fish or fish oil or soy.
结局指标
主要结局
Change From Baseline in Rey Auditory Verbal Learning Test
时间窗: baseline, 15 wk
A widely used, brief, easy to understand scale to evaluate verbal learning and memory. The score is presented as the number of words correctly recalled (0 is worse, 15 is best).The total learning task score ranges from 0 to 45 words(0 is worse, 45 is best).
次要结局
- Blood Work(baseline,15 wk)
- Trail Making Test(Baseline, 15 weeks)
- Computerized Cognitive Assessment Tool(baseline, 15 weeks)
- Clinical Global Impression of Change (CGI-C)Scale(7 weeks, 15 weeks)
- Change From Baseline in Rey Osterrieth Complex Figure Test(baseline, 15 weeks)
研究者
研究点 (2)
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