NL-OMON49197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) - A Study of Neflamapimod in Subjects with DLB.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
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 99（—）
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
- •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.
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
- •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
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