NCT02211560终止不适用
A, Multi-center, Double-blind, Randomized, Placebo-controlled Study for the Efficacy of Phosphatidylserine in Mild Cognitive Impairment (MCI)
Enzymotec24 个研究点 分布在 2 个国家目标入组 97 人开始时间: 2014年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 97
- 试验地点
- 24
- 主要终点
- Difference in change in the Selective Reminding Test (SRT) between the study groups.
研究概览
简要总结
The primary objective is to evaluate the efficacy and safety of phosphatidylserine (PS) on cognitive abilities in MCI
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 65 and less than or equal to 85 years.
- •Formal education greater than or equal to 10 years.
- •Male or female with a diagnosis of Mild Cognitive Impairment (MCI)
- •Male or female with a diagnosis of Mild Cognitive Impairment (MCI) as defined by Peterson, according to The following:
- •3.1 Clinical Dementia Rating Scale total score (CDR) ≤0.5, and score of each one of the six categories ("box scores") ≤
- •3.2 Mini Mental State Exam > 24 3.3 Verbal Paired-Associated Learning test score according to the following ages: Ages 65-70 less than or equal to 18 Ages 71-85* less than or equal to 17
- •*Eligibility of subjects aged between 70 and 71 (i.e., 70.1) will be evaluated according to 71-85 age group score.
- •Adequate vision, hearing, and literacy ability to allow for neuropsychological testing.
- •Able and willing to perform all study procedures.
- •Ability to provide written consent signed by the subject
排除标准
- •Any significant neurological condition or disorder (e.g., seizure disorder, epilepsy, brain tumors, stroke, etc.) that could cause cognitive deterioration other than suspected MCI.
- •Any medical condition or disorder that could produce cognitive deterioration (i.e., renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances) unless well controlled for at least 3 months.
- •Clinically significant abnormal serum TSH and/or B-12 and/or folic acid levels below the normal range.
- •History of any infective or inflammatory brain disease including viral, fungal or syphilitic etiologies.
- •Head trauma or injury immediately preceding cognitive deterioration, unless over 2 years have passed since full cognitive and functional recovery.
- •Depression at screening as assessed by Geriatric Depression Scale-short version (score ≥5)
- •Current suicidality at screening by Columbia Suicidality Severity Rating Scale.
- •Dementia by DSM-IV criteria.
- •Concomitant use of medications with potent psychotropic properties (e.g. antipsychotics, ADHD treatments, lithium carbonate, anti-epileptic drugs such as Gabapentin). Sedating antihistamines are allowed if administered last dose is administered at least 12 hours before cognitive testing. Usage of prescription or nonprescription antidepressant agents, lipid lowering medications, and anti-hypertensive medications with a stable dosage for more than 2 months prior study entry is permitted.
- •Concomitant use of any medications approved for the symptomatic treatment of dementia due to AD (e.g., NMDA, acetyl choline esterase inhibitors)
- •Use within 3 weeks prior to study entry of any medications with any anti-cholinergic effect (e.g. Atropine, Scopolamine, Tolterodine, Hyoscyamine, Biperiden, Benzatropine, Trihexyphenidyl, Oxybutynin).
- •Use within 4 weeks prior to the study entry of dietary supplements containing DHA, EPA, Phosphatidylserine, Phosphatidylcholine (e.g. Krill oil, Lecithin), or alpha-glycerphosphocholine (GPC).
- •Use within 4 weeks prior to the study entry of medical foods indicated for cognitive or memory impairment [e.g. Axona, Cerefolin, CerefolinNAC, Souvenaid].
- •Concomitant use of any supplements containing ingredients with nootropic or vasodilator properties (e.g., Ginkgo Biloba, Vinpocetine, Piracetam, high energy supplements).
- •Use of an investigational drug within the last 30 days.
- •Allergic reaction or sensitivity to marine products (fish/seafood) and/or soy.
- •Any known condition which in the opinion of the investigator may be possibly causing cognitive impairment other than AD (mania, alcohol or substance abuse, mental retardation, bipolar disorder, panic disorder, obsessive compulsive disorder, post-traumatic stress disorder, psychotic disorder, major psychiatric disorder preceding dementia onset or affecting brain function, major surgery ) and/or limits the successful trial completion
研究组 & 干预措施
Placebo
Placebo Comparator
Identical looking cellulose capsules
干预措施: Placebo (Other)
Phosphatidylserine
Experimental
Phosphatidylserine-omega-3, DHA enriched
干预措施: Phosphatidylserine (Other)
结局指标
主要结局
Difference in change in the Selective Reminding Test (SRT) between the study groups.
时间窗: baseline, 3, 6,12 months
次要结局
- Transition rate to dementia according to DSM-4 criteria(baseline, 3, 6, 12, 18 and 24 months)
- Mini Sleep Questionnaire (MSQ)(baseline, 12 and 24 months)
- Hamilton Anxiety Rating Scale (HAM-A).(baseline, 12 and 24 months)
- Mini Mental State Examination (MMSE)(baseline, 12 and 24 months)
- Computerized Neurological battery test (NBT)(baseline, 6, 12 and 24 months)
- Selective Reminding Test (SRT)(18 and 24 months)
研究者
研究点 (24)
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