A Phase 2a Study of MW150 Stress Kinase Inhibitor in Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Drug Safety- Blood tests
研究概览
简要总结
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)
盲法说明
Subjects will be randomized through a computerized system by a Data/Statistics Group independent from the investigator or Sponsor
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
- 否
入选标准
- •Signed informed consent from subject (or legally authorized representative, LAR) and study partner.
- •Male or female, age 50 to 90 inclusive.
- •Have a study partner who is able to accompany the subject, has frequent contact with subject.
- •Meet criteria for Alzheimer's Disease by NIAA-AA criteria.
- •Must speak English fluently.
- •Must have education of at least 8 years.
- •Must have adequate hearing and visual abilities.
- •MMSE score of 14 to
- •Clinical Dementia Rating (CDR) Global score of 0.5 to 2.0 inclusive.
- •Absence of suicidal ideation for at least 1 year.
- •Absence of medical conditions that could affect ability to participate in study.
- •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.
- •Stable neuropsychiatric medications for at least 2 months prior to screening.
- •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.
- •If male, must agree to use contraception if with a potentially childbearing partner.
排除标准
- •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).
- •Serious or unstable hematologic, hepatic, renal, pulmonary, cardiac, or other medical disease.
- •Abnormal liver function tests (ALT or AST) or creatine kinase (CK) upon repeat testing.
- •Chronic hepatitis B or C infection, indicated by positive HBSAg, or HCV-Ab with HCV RNA presence.
- •Known history of human immunodeficiency virus (HIV) infection.
- •Known immune disorder that has a history of requiring treatment with immunosuppressive drugs within the past 1 year.
- •Have a drug or alcohol abuse within 12 months prior to screening.
- •Clinically significant laboratory abnormalities at screening.
- •Screening ECG showing repeated QTcF > 480 msec, or other clinically significant ECG abnormalities.
- •Clinically significant structural brain abnormalities, such as hydrocephalus or intra-axial brain tumors.
- •Participation in another investigational study within 30 days or 5 half-lives prior to screening, whichever is greater.
- •Participation in another study that would have cognitive testing during the duration of this study.
- •History of Covid19 or other viral infections within 3 months.
- •Have a clinically significant medical, surgical, laboratory, or behavioral abnormality, which in the judgment of the Investigator makes the subject unsuitable for the study.
研究组 & 干预措施
10mg MW150 daily
10 mg MW150 daily (1 capsule of 10 mg daily)
干预措施: MW150 (Drug)
placebo daily
placebo daily (1 capsule of matched placebo daily)
干预措施: Placebo (Drug)
结局指标
主要结局
Drug Safety- Blood tests
时间窗: 84 days treatment
Number of participants with treatment-related adverse events as assessed by laboratory test abnormalities.
Drug Safety- C-SSRS
时间窗: 84 days treatment
Development of any suicidality on COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS) score (minimum 0, no maximum, higher number worse).
Drug Tolerability- Adverse events
时间窗: 84 days treatment
Incidence of adverse events (AE).
Drug Safety- Electrocardiographic
时间窗: 84 days treatment
Number of participants with emergent abnormal electrocardiograms.
次要结局
- Functional performance- ADCS-ADL(84 days treatment)
- Functional performance-CDR(84 days treatment)
- Pharmacodynamics - cytokines(84 days treatment)
- Cognitive change-Language(84 days treatment)
- Cognitive change-MMSE(84 days treatment)
- Pharmacodynamics - neuronal biomarkers(84 days treatment)
- Cognitive change-ADAScog(84 days treatment)
- Cognitive change-Executive(84 days treatment)
- Behavioral Scale - NPI-Q(84 days treatment)
研究者
Lawrence S Honig, MD, PhD, FAAN
Professor of Neurology at Columbia University Irving Medical Center
Columbia University