An Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNK 754 in Elderly Volunteers and in Subjects With Mild Alzheimer's Disease
A Double-Blind, Randomized, Placebo-Controlled, Multiple, Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNK 754 in Elderly Volunteers and in Subjects With Mild Alzheimer's Disease
研究概览
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
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Arizona
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Phoenix、Arizona、美国、85013
- Dedicated Phase I
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California
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Long Beach、California、美国、90806
- Collaborative NeuroScience Network
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Florida
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Miami、Florida、美国、33169
- Elite Research Insitute
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Orlando、Florida、美国、32806
- Compass Research, LLC
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Georgia
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Atlanta、Georgia、美国、30308
- Atlanta Center for Medical Research
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Missouri
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St. Louis、Missouri、美国、63118
- St. Louis Clinical Trials, LC
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Texas
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Houston、Texas、美国、77074
- Clinical Trial Network
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Part A and Part B:
- Males or females aged 60 years or older. Females must be surgically sterilized or postmenopausal for at least two years. Males must be actively practicing double-barrier contraception (condom plus spermicide), unless they have had a vasectomy, or their partner(s) meet the above criteria for females.
- Voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures.
Be prepared to adhere to the protocol requirements and be willing and able to remain in the study unit for the entire duration of the confinement period. They must also be willing to return for the End-of-Study Visit one week after the last dosing.
Part A only:
Subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. Subjects may be included with clinical deviations from normal limits in medical history, physical examination, vital sign measurements, ECG, or laboratory test results that are associated with stable, well controlled chronic illness. Subjects with concomitant diseases or using concomitant medication will be allowed to participate provided a stable condition and stable treatment for 1 month (30 days) prior to administration of the first dose of study medication. Inclusion of each subject will be reviewed with the Link Medical Monitor prior to enrollment in the trial.
Part B only:
- Subjects with Mild Alzheimer's Disease, as defined by DSM-IV.
- Subjects with a score of ≥ 18-26 on the Mini-Mental State Examination (MMSE).
- Subjects with a Clinical Dementia Rating (CDR) total score of 0.5 or 1.0 (possible or mild dementia).
- Subjects with a Rosen-Modified Hachinski Ischemic score of ≤ 4.
Exclusion Criteria:
Part A and Part B:
- Any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease, as determined by medical history, physical examination or laboratory tests.
- Subjects who have positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- Subjects who have received any experimental drugs or devices within 30 days prior to dosing or who wish to receive any experimental drug within 30 days after completing the study.
- Subjects unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较:安慰剂
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Escalating dose
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有源比较器:Multiple Dose
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Escalating dose
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Safety assessments to include pharmacokinetics, and adverse events
大体时间:24 hours
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24 hours
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合作者和调查者
调查人员
- 首席研究员:Abel Murillo, MD、Elite Research Institute
- 首席研究员:Craig T. Curtis, MD、Compass Research
- 首席研究员:Kyle Patrick, D.O.、Dedicated Phase I
- 首席研究员:Maxwell Axler, MD、Clinical Trial Network
- 首席研究员:Ricky S. Mofsen, D.O.、St. Louis Clinical Trials, LC
- 首席研究员:Armen Goenjian, MD、Collaborative NeuroScience Network
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
LNK-754的临床试验
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