NCT01072812终止1 期
An Open-Label, Two-Stage Study to Evaluate the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Plasma and CSF After a 10-Day Treatment Period in Subjects With Amnestic Mild Cognitive Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
This trial will determine the pharmacokinetics of Posiphen® in both plasma and CSF after a 10-day treatment period with Posiphen® in subjects with amnestic MCI. The effects of this treatment on biomarkers will also be determined in CSF, whole blood, and plasma or serum as primary pharmacodynamic (PD) objectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or post-menopausal females aged 55 to 80 years, inclusive.
- •Must have Mild Cognitive Impairment (MCI) (amnestic subtype) according to Petersen's criteria (2004).
- •Mini Mental Status Examination (MMSE) score should be ≥
- •Must score below a pre-determined cut-off score on the logical memory II delayed paragraph recall sub-test of the Wechsler Memory Scale Revised (WMS-R).
- •Must have a Clinical Dementia Rating of 0.5 with a memory box score of 0.5 or 1.
- •Modified Hachinski score of less than or equal to
- •Hamilton Depression rating scale (HAMD17) score of less than or equal to 12 with a score of 0 on items 1, 2, and 3 (depressed mood, feelings of guilt, and suicidal ideation).
- •No evidence of current suicidal ideation or previous suicide attempt in past 2 years as evaluated in the Columbia Suicidality Checklist.
- •MRI scans within 12 months prior to screening, or per screening MRI, without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease.
- •No clinically significant abnormalities in the lumbar spine should be present on a lumbar X-ray that would contraindicate lumbar puncture.
- •Adequate visual and hearing ability (physical ability to perform all the study assessments).
- •Normal B12, folic acid, and thyroid function tests (thyroid stimulating hormone [TSH], free T4, and free T3).
- •Do not require nursing home care.
排除标准
- •Any significant neurologic disease other than amnestic MCI, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- •Major depression, schizophrenia or another major psychiatric disorder as described in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) within the past 2 years.
- •Psychotic features, agitation, or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
- •History of alcohol or substance abuse or dependence within the past 2 years.
- •Subjects with any febrile illness within 1 week prior to the CSF collection.
- •Subjects who have history of migraine headaches and any other type of headaches of at least moderate severity more than twice per month.
- •Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol or pose potential risk to the subjects.
- •Use of medications prohibited by the study.
- •Any clinically significant laboratory abnormalities.
- •Subjects with infection or inflammation of the skin or skin disease at or in proximity to the lumbar puncture site.
- •History of lumbar spine surgery or chronic low back pain (CLBP).
研究组 & 干预措施
Posiphen® tartrate capsules
Experimental
干预措施: Posiphen® tartrate capsules (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 10 days
To determine the pharmacokinetics (PK) of Posiphen® and its metabolites in plasma and CSF after a 10-day treatment period with Posiphen®.
Pharmacodynamics
时间窗: 10 days
To assess the effects of a 10-day treatment period with Posiphen® on the levels of amyloid precursor protein (APP), amyloid β protein 40 (Aβ40), amyloid β protein 42 (Aβ42), acetylcholinesterase (AChE), and butyrylcholinesterase (BChE) in plasma and CSF from subjects with amnestic MCI.
次要结局
- Biomarkers(10 days)
- Safety(10 days)
研究者
研究点 (1)
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