EUCTR2019-001566-15-NL进行中（未招募）1 期
A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of the Oral P38 Alpha Kinase Inhibitor Neflamapimod in Dementia with Lewy Bodies (DLB)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Men and women aged =55 years.
- •2.Subject or subject’s legally authorized representative is willing and able to provide written informed consent.
- •3.Probable DLB and identified cognitive deficits, according to current consensus criteria (McKeith et al, 2017), specifically one core clinical feature and a positive DaTscan. If a negative DaTscan, but the subject has historical PSG-verified RBD, the subject would also qualify.
- •4.MMSE score of 15-28, inclusive, during Screening.
- •5.Currently receiving cholinesterase inhibitor therapy, having received such therapy for greater than 3 months and on a stable dose for at least 6 weeks at the time of randomization. Except for reducing the dose for tolerability reasons, the dose of cholinesterase inhibitor may not be modified during the study.
- •6.Normal or corrected eye sight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments.
- •7.No history of learning difficulties that may interfere with their ability to complete the cognitive tests.
- •8.Must have reliable informant or caregiver.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 51
排除标准
- •1.Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB, including, but not limited to, post-stroke dementia, vascular dementia, Alzheimer’s disease (AD), or Parkinson’s disease (PD).
- •2.Suicidality, defined as active suicidal thoughts within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the C-SSRS, or history of suicide attempt in previous 2 years, or, in the Investigator’s opinion, at serious risk of suicide.
- •3.Ongoing major and active psychiatric disorder and/or other concurrent medical condition that, in the opinion of the Investigator, might compromise safety and/or compliance with study requirements.
- •4.Diagnosis of alcohol or drug abuse within the previous 2 years.
- •5.Poorly controlled clinically significant medical illness, such as hypertension (blood pressure >180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would interfere with assessment of drug safety.
- •6.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × the upper limit of normal (ULN), total bilirubin >1.5 × ULN, and/or International Normalized Ratio (INR) >1.5.
- •7.Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection.
- •8.Participated in a study of an investigational drug less than 3 months or 5 half-lives of an investigational drug, whichever is longer, before enrollment in this study.
- •9.History of previous neurosurgery to the brain.
- •10.If male with female partner(s) of child-bearing potential, unwilling or unable to adhere to contraception requirements specified in the protocol.
- •11.If female who has not has not reached menopause >1 year previously or has not had a hysterectomy or bilateral oophorectomy/salpingo-oophorectomy, has a positive pregnancy test result during Screening and/or is unwilling or unable to adhere to the contraception requirements specified in the protocol.
研究者
相似试验
已完成
2 期
A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of the Oral P38 Alpha Kinase Inhibitor Neflamapimod in Dementia with Lewy Bodies (DLB)Dementia with Lewy Bodies (DLB)neurodegenerative disease10012272dementiaNL-OMON49197EIP Pharma Inc.13
进行中（未招募）
不适用
Study to evaluate the efficacy and safety of a drug called reslizumab performed by comparing simultaneously 3 groups of patients aged from 12 to 75 years suffering from eosinophilic asthma and receiving during 16 weeks, either reslizumab at a dose of 0.3mg/kg or at a dose of 3mg/kg or a placebo (inactive substance). Treatment given to each patient will be drawn at random, without both the patient and the physician knowing which one has been attributed.Treatment for patients with eosinophilic asthmaMedDRA version: 14.1Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855EUCTR2010-023342-67-HUTeva Branded Pharmaceutical Products R&D, Inc.300
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of a drug called reslizumab performed by comparing simultaneously 3 groups of patients aged from 12 to 75 years suffering from eosinophilic asthma and receiving during 16 weeks, either reslizumab at a dose of 0.3mg/kg or at a dose of 3mg/kg or a placebo (inactive substance). Treatment given to each patient will be drawn at random, without both the patient and the physician knowing which one has been attributed.Treatment for patients with eosinophilic asthmaMedDRA version: 14.1Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855EUCTR2010-023342-67-BETeva Branded Pharmaceutical Products R&D, Inc.300
已完成
3 期
A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) with Eosinophilic Asthma.eosinophlic asthma10006436NL-OMON36320Cephalon Inc6
进行中（未招募）
不适用
Study to evaluate the efficacy and safety of a drug called reslizumab performed by comparing simultaneously 3 groups of patients aged from 12 to 75 years suffering from eosinophilic asthma and receiving during 16 weeks, either reslizumab at a dose of 0.3mg/kg or at a dose of 3mg/kg or a placebo (inactive substance). Treatment given to each patient will be drawn at random, without both the patient and the physician knowing which one has been attributed.Treatment for patients with eosinophilic asthmaMedDRA version: 16.1Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855EUCTR2010-023342-67-SETeva Branded Pharmaceutical Products R&D, Inc.300