NCT01492374已完成1 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease
Bristol-Myers Squibb15 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2012年2月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 15
- 主要终点
- Safety assessments: based on frequency of Serious Adverse Events (SAEs), frequency of Adverse events (AEs), discontinuation due to AEs and dose reduction
研究概览
简要总结
The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027 on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly intravenous (IV) infusions of BMS-241027
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)
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
- •Mild AD Subjects meeting National Institute of Neurological Disorders and Stroke - Alzheimer's Disease Related Disorders Association(NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-Forth Edition, Text Revision (DSM-IV-TR) criteria
- •Mini-Mental State Exam (MMSE) Score between 20 & 26 (inclusive)
- •CSF consistent with AD pathology
- •Screening brain MRI - normal - commensurate with age or demonstrate atrophy consistent with AD diagnosis (dx); reveal no more than mild white matter disease; up to 2 lacunar infarcts acceptable except in anterior thalamus, genu of internal capsule or basal forebrain; reveal no cortical infarcts; reveal no more than 4 microbleeds; reveal no focal asymmetric lobar atrophy or other findings suggesting primary cause of dementia is attributed to a cause other than AD; reveal no macrohemorrhages (>10 mm)
- •Subjects must have reliable study partners
- •Men and Women of Non Child Bearing Potentia (WONCBP), ages 50-90 years
排除标准
- •Subjects with any other medical condition other than mild AD that could explain subjects' memory or cognitive deficits
- •Subjects diagnosed with moderate or severe AD per DSM-IV criteria
- •Subjects with a history (hx) of stroke
- •Subjects with a hx of GI illnesses
- •Subjects with Vitamin B12 or folate deficiency
- •Subjects with any unstable cardiovascular (CV), pulmonary, Gastrointestinal (GI) or hepatic disease within 30 days prior to screening
- •Subjects with active liver dx or history of hepatic intolerance
- •Subjects with a Geriatric Depression Scale score of ≥ 6 at screening
- •Subjects treated for or have had a diagnosis of schizophrenia
- •Subjects treated for or have had a diagnosis of bipolar disease within 3 years prior to screening
- •Subjects with a history of generalized peripheral neuropathy
研究组 & 干预措施
Arm 1: BMS-241027 (0.003 mg/kg)
Experimental
干预措施: BMS-241027 (Drug)
Arm 2: BMS-241027 (0.01 mg/kg)
Experimental
干预措施: BMS-241027 (Drug)
Arm 3: BMS-241027 (0.03 mg/kg)
Experimental
干预措施: BMS-241027 (Drug)
Arm 4: Placebo matching BMS-241027
Experimental
干预措施: Placebo matching BMS-241027 (Drug)
结局指标
主要结局
Safety assessments: based on frequency of Serious Adverse Events (SAEs), frequency of Adverse events (AEs), discontinuation due to AEs and dose reduction
时间窗: Within the first 70 day after first dose
Biomarker Measures: CSF levels of Tau N-terminal domain fragments
时间窗: Within the first 70 day after first dose
次要结局
- Effects of BMS-241027 on connectivity MRI(Within the first 70 days after first dose)
- Effects of BMS-241027 on CSF levels of neurofilaments(Within the first 70 days after first dose)
- Effects of BMS-241027 on CSF levels of the mid-domain Tau fragment(Within the first 70 days after first dose)
- Effects of BMS-241027 on cognitive performance using computerized cognitive tests(Weeks 3, 6 and 9)
- Observed plasma concentration at 24 hours post dose (C24) of BMS-241027 in subjects with mild Alzheimer's disease(Weeks 1, 4, and 9)
- Maximal observed plasma concentration (Cmax) of BMS-241027 in subjects with mild Alzheimer's disease(Weeks 1, 4, and 9)
- Time of maximal observed plasma concentration (Tmax) of BMS-241027 in subjects with mild Alzheimer's disease(Weeks 1, 4, and 9)
- Safety assessments: based on vital sign measurements, ECGs and clinical laboratory tests(Within the first 70 day after first dose)
- Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-241027 in subjects with mild Alzheimer's disease(Weeks 1, 4, and 9)
研究者
研究点 (15)
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