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MW150 Stress Kinase Inhibitor in Mild to Moderate Alzheimer's Disease (SKI-AD)

2022年3月13日 更新者:Lawrence S Honig, MD, PhD, FAAN、Neurokine Therapeutics

A Phase 2a Study of MW150 Stress Kinase Inhibitor in Mild to Moderate Alzheimer's Disease

This study is a phase 2a randomized double-blind, placebo-controlled, study, in mild-to-moderate Alzheimer's disease, of the oral investigational drug MW150, a p38alphaMAPK kinase inhibitor. The primary goals of this study are to investigate the safety and tolerability, and drug movements in the body. The secondary goals of the study are to investigate the effects of the drug on cognitive performance, activities of daily living, and behavior, and the biological effects of the drug on blood biomarkers.

研究概览

地位

尚未招聘

研究类型

介入性

注册 (预期的)

24

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • New York
      • New York、New York、美国、10032

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 90年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Signed informed consent from subject (or legally authorized representative, LAR) and study partner.
  2. Male or female, age 50 to 90 inclusive.
  3. Have a study partner who is able to accompany the subject, has frequent contact with subject.
  4. Meet criteria for Alzheimer's Disease by NIAA-AA criteria.
  5. Must speak English fluently.
  6. Must have education of at least 8 years.
  7. Must have adequate hearing and visual abilities.
  8. MMSE score of 14 to 28.
  9. Clinical Dementia Rating (CDR) Global score of 0.5 to 2.0 inclusive.
  10. Absence of suicidal ideation for at least 1 year.
  11. Absence of medical conditions that could affect ability to participate in study.
  12. MRI within 1 year of screening, not showing clinically significant structural lesions. Subjects without available MRI within 1 year, must have an MRI performed for eligibility.
  13. Stable neuropsychiatric medications for at least 2 months prior to screening.
  14. If female, must not be of childbearing potential, as defined by being postmenopausal (more than 1 year without periods) or surgically sterile for at least 6 months prior to screening.
  15. If male, must agree to use contraception if with a potentially childbearing partner.

Exclusion Criteria:

  1. Presence of clinically significant disorders of the central nervous system other than Alzheimer's disease, such as Lewy Body Disease, Parkinson's disease, hydrocephalus, epilepsy, demyelinating disease, brain tumors, or psychiatric disorders (such as schizophrenia, or severe affective disorders).
  2. Serious or unstable hematologic, hepatic, renal, pulmonary, cardiac, or other medical disease.
  3. Abnormal liver function tests (ALT or AST) or creatine kinase (CK) upon repeat testing.
  4. Chronic hepatitis B or C infection, indicated by positive HBSAg, or HCV-Ab with HCV RNA presence.
  5. Known history of human immunodeficiency virus (HIV) infection.
  6. Known immune disorder that has a history of requiring treatment with immunosuppressive drugs within the past 1 year.
  7. Have a drug or alcohol abuse within 12 months prior to screening.
  8. Clinically significant laboratory abnormalities at screening.
  9. Screening ECG showing repeated QTcF > 480 msec, or other clinically significant ECG abnormalities.
  10. Clinically significant structural brain abnormalities, such as hydrocephalus or intra-axial brain tumors.
  11. Participation in another investigational study within 30 days or 5 half-lives prior to screening, whichever is greater.
  12. Participation in another study that would have cognitive testing during the duration of this study.
  13. History of Covid19 or other viral infections within 3 months.
  14. Have a clinically significant medical, surgical, laboratory, or behavioral abnormality, which in the judgment of the Investigator makes the subject unsuitable for the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:10mg MW150 daily
10 mg MW150 daily (1 capsule of 10 mg daily)
oral-delivered capsule of study drug
其他名称:
  • MW01-18-150SRM
安慰剂比较:placebo daily
placebo daily (1 capsule of matched placebo daily)
oral delivered capsule matched to study drug capsule

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Drug Safety- Blood tests
大体时间:84 days treatment
Number of participants with treatment-related adverse events as assessed by laboratory test abnormalities.
84 days treatment
Drug Safety- Electrocardiographic
大体时间:84 days treatment
Number of participants with emergent abnormal electrocardiograms.
84 days treatment
Drug Safety- C-SSRS
大体时间:84 days treatment
Development of any suicidality on COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS) score (minimum 0, no maximum, higher number worse).
84 days treatment
Drug Tolerability- Adverse events
大体时间:84 days treatment
Incidence of adverse events (AE).
84 days treatment

次要结果测量

结果测量
措施说明
大体时间
Cognitive change-MMSE
大体时间:84 days treatment
Change in MiniMental State Examination (MMSE) score (0-30, higher score better).
84 days treatment
Cognitive change-ADAScog
大体时间:84 days treatment
Change in Alzheimer's Disease Assessment Scale (ADAScog) score (0-70, higher score worse).
84 days treatment
Cognitive change-Executive
大体时间:84 days treatment
Change in Trails A (0 - 150 sec) and Trails B test scores (0-300 sec), higher scores worse.
84 days treatment
Cognitive change-Language
大体时间:84 days treatment
Change in Verbal Fluency tests for animals and letters (both minimum 0, no maximum, higher scores better).
84 days treatment
Functional performance- ADCS-ADL
大体时间:84 days treatment
Change in Alzheimers Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale (0 - 78, higher score better).
84 days treatment
Functional performance-CDR
大体时间:84 days treatment
Change in Clinical Disease Rating Scale (0 - 3, higher score worse).
84 days treatment
Behavioral Scale - NPI-Q
大体时间:84 days treatment
Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) (0-36, higher scores worse).
84 days treatment
Pharmacodynamics - cytokines
大体时间:84 days treatment
Changes in biomarker measurements of plasma levels of cytokines (IFN-γ, IL-1β, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12P70, IL-22, and TNFα) by Simoa assay (pg/mL).
84 days treatment
Pharmacodynamics - neuronal biomarkers
大体时间:84 days treatment
Changes in biomarker measurements of plasma levels of tau protein and NfL protein by Simoa assay (pg/mL).
84 days treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Lawrence S Honig, MD PhD、Columbia University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年5月1日

初级完成 (预期的)

2024年8月31日

研究完成 (预期的)

2024年11月30日

研究注册日期

首次提交

2022年1月13日

首先提交符合 QC 标准的

2022年1月14日

首次发布 (实际的)

2022年1月18日

研究记录更新

最后更新发布 (实际的)

2022年3月29日

上次提交的符合 QC 标准的更新

2022年3月13日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • MW150-AD-201
  • R44AG071388 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Once study complete, de-identified participant data will be shared upon request by investigators from an academic institution.

IPD 共享时间框架

ICF will be shared at onset of enrollment. Study Protocol and SAP will be shared once study published. CSR will be shared once completed.

IPD 共享访问标准

Protocol, SAP will be shared via publication. CSR will be shared upon request

IPD 共享支持信息类型

  • 研究协议
  • 统计分析计划 (SAP)
  • 知情同意书 (ICF)
  • 临床研究报告(CSR)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

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.

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