NCT02423122已完成2 期
A Clinical Study of Two Doses of a Selective p38 MAP Kinase Inhibitor, VX-745, to Evaluate the Effects of 12-Week Oral Twice-Daily Dosing on Amyloid Plaque Load as Assessed by Quantitative Dynamic 11C-PiB Positive Emission Tomography (PET) Amyloid Scanning
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of 11C-PiB Responders
研究概览
简要总结
This study will assess the effects of administration of VX-745 for 12 weeks on amyloid plaque burden in Alzheimer's disease (AD). Subjects who meet entry criteria will undergo 11C-PiB (Carbon-11-labeled Pittsburgh Compound B) positron emission tomography (PET) at baseline and after 45 days of dosing with VX-745. Cognitive testing will also be conducted at baseline and day 45.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent
- •Diagnosis of mild cognitive impairment (MCI) due to probable AD or of mild AD
- •MMSE range: 20 to 28
- •Evidence of amyloid pathology by amyloid PET scan
- •Participants may be taking medications for AD, provided that the dose of these medications has been stable for >3 months
- •Proficiency in Dutch and adequate visual and auditory abilities to be able to perform all aspects of the cognitive and functional tests
- •Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
排除标准
- •Evidence of neurodegenerative disease other than AD
- •Inability for any reason to undergo PET and fMRI scans (including notably: history of allergic reaction of any severity to 11C-PiB injection; pacemaker, vascular stent or stent graft)
- •Psychiatric disorder that would compromise ability to comply with study requirements
- •Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder or metabolic/endocrine disorders or other disease that would preclude treatment with p38 MAP kinase inhibitor and/or assessment of drug safety and efficacy
- •Recent (<90 days) changes to AD medications prescribed for cognitive reasons or with the potential to impact cognition
- •Participation in a study of an investigational drug less than 6 months or 5 half-lives of the investigational drug, whichever is longer, before enrollment in the study
- •Male subjects with female partner of child-bearing potential who are unwilling or unable to adhere to contraception requirements
- •Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingoophorectomy
- •Positive urine or serum pregnancy test or plans desires to become pregnant during the course of the trial
- •Any factor deemed by the investigator to be likely to interfere with study conduction
研究组 & 干预措施
VX-745 dose 1
Experimental
Active Group 1: VX-745 40 mg twice daily
干预措施: VX-745 (Drug)
VX-745 dose 2
Experimental
Active Group 2: VX-745 125 mg twice daily
干预措施: VX-745 (Drug)
结局指标
主要结局
Number of 11C-PiB Responders
时间窗: Day 84
Number of patients meeting protocol pre-specified definition of response: \> 7% reduction in global cortical BPND
Percent Change From Baseline in Amyloid Plaque Burden by 11C-PiB PET
时间窗: Baseline compared to following 12 weeks' dosing with VX-745
Percent change in global cortical amyloid specific PET signal (BPND)
次要结局
- Wechsler Memory Scale (WMS) Immediate Recall Composite(Baseline to Day 84)
- Wechsler Memory Scale (WMS) Delayed Recall Composite(Change from baseline to Day 84)
研究者
研究点 (1)
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