NL-OMON50754招募中3 期
Open label extension study for patients with early Alzheimer's Disease (AD) enrolled in study ANAVEX2-73-AD-004 - ANAVEX2-73-AD-EP-004
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 10
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. Previous completion of participation in the ANAVEX2-73-AD-004 double-blind
- •2. Participants may be either outpatients, or residents of an assisted-living
- •3. Participants must have a designated study partner, who spends at least 10 hr
- •with the participant, in order for assessments (e.g., carer burden instruments)
- •completed with sufficient knowledge of the participant.
- •4. No suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating
- •Scale (CSSRS)
- •in the past 3 months (i.e., active suicidal thought(s) with intent but without
- •specific plan, or active suicidal thought(s) with plan and intent) OR suicidal
- •in the past 2 years (i.e., actual attempt, interrupted attempt, aborted
- •attempt, or
- •preparatory acts or behavior).
- •5. Confirmation from the participant that, if of childbearing potential, is not
- •through urine pregnancy testing.
排除标准
- •1. Adverse events (AEs) from the previous study (ANAVEX2-73-AD-004) that have
- •not resolved, are moderate or severe, judged to be possibly related or related
- •drug, and considered by the investigator to be a contraindication to extension
- •participation.
- •2. Any condition or laboratory abnormality that would make the subject, in the
- •of the investigator, unsuitable for the study.
- •3. Significant history of drug addiction (with the exception of nicotine
- •dependence) or
- •abuse (including alcohol, as defined in DSM-5 or in the opinion of the
- •investigator)
- •within the last two years prior to informed consent, or a positive urine drug
- •cocaine, opioid, phencyclidine (PCP), amphetamine or marijuana at baseline.
- •Prescription medication yielding a positive drug screen are acceptable except
- •tricyclic antidepressants.
- •4. Any known hypersensitivity to any of the excipients contained in the study
- •formulation.
研究者
相似试验
进行中（未招募）
1 期
ANAVEX2-73 Extension Study for treatment in ADMedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Alzheimer's DiseaseEUCTR2021-004325-80-NLAnavex Germany GmbH325
进行中（未招募）
1 期
An open-label study to evaluate the extended early bactericidal activity, safety, tolerability and pharmacokinetics of multiple doses (m.d.) of TMC207 oral solution (os) and isoniazid (JH), m.d. of TMC207 os and pyrazinamide (JZ), m.d. of TMC207 os and rifampin (JR) or m. oral d. of TMC207 os and isoniazid and pyrazinamide (JHZ), compared to the 3 principle drugs of standard anti-tuberculosis treatment (HRZ) in treatment-naïve subjects with sputum-smear positive pulmonary tuberculosis. - N/ATuberculosisEUCTR2004-005142-12-GBTibotec Pharmaceuticals Limited60
进行中（未招募）
1 期
A study for participants with Spinal Muscular Atrophy (SMA) who previously participated in nusinersen (ISIS 396443) investigational studiesEUCTR2015-001870-16-BEBiogen Idec Research Limited292
进行中（未招募）
1 期
A study for participants with Spinal Muscular Atrophy (SMA) who previously participated in nusinersen (ISIS 396443) investigational studiesEUCTR2015-001870-16-GBBiogen Idec Research Limited292
进行中（未招募）
1 期
A study for participants with Spinal Muscular Atrophy (SMA) who previously participated in nusinersen (ISIS 396443) investigational studiesSpinal Muscular Atrophy (SMA)MedDRA version: 20.1Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2015-001870-16-SEBiogen Idec Research Limited292