CTIS2023-504373-20-00进行中（未招募）1 期
A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Dementia with Lewy Bodies (DLB) - EIP21-NFD-504
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Men and women aged =55 years., Subject is willing and able to provide written informed consent., Probable DLB by consensus criteria, including a positive DaTscan™. If the DaTscan is negative, but the subject has historical polysomnography (PSG)-verified REM sleep behavioral disorder (RBD), this will also qualify as probable DLB., CDR Global Score less than 2.0 at Screening., If the patient is currently receiving cholinesterase inhibitor therapy, the patient must have received such therapy for greater than 3 months and on a stable dose for at least 6 weeks at the time of randomization. If the patient is not currently receiving cholinesterase inhibitor therapy, that therapy must have been discontinued at least 3 months prior to randomization., Normal or corrected eyesight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments., No history of learning difficulties that may interfere with their ability to complete the cognitive tests., Received vaccination for SARS-CoV-19 unless medical contraindications prevent being vaccinated or has a history of natural infection., Must have reliable informant or caregiver.
排除标准
- •Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB)., History of previous neurosurgery to the brain within the past five years., Unwilling or unable to adhere to contraception requirements specified in the protocol., If female has a positive pregnancy test result during Screening and/or is unwilling or unable to adhere to the contraception requirements specified in the protocol., Plasma ptau181 result above the threshold that indicates evidence of pathology associated with Alzheimer’s disease at Screening., Suicidality, defined as active suicidal thoughts within 6 months before Screening or at Baseline or history of suicide attempt in previous 2 years, or, in the Investigator’s opinion, at serious risk of suicide., 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., Diagnosis of alcohol or drug abuse within the previous 2 years., Poorly controlled clinically significant medical illness or other disease that would interfere with assessment of drug safety., 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., Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection., Participated in a study of an investigational drug less than six weeks or 5 half-lives of an investigational drug, whichever is longer, before enrollment in this study.
研究者
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