EUCTR2014-002855-25-NL进行中（未招募）1 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
EIP Pharma, LLC0 个研究点开始时间: 2014年11月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men and women age 60-85 years.
- •2. Willing and able to provide informed consent.
- •3. Confirmed diagnosis of mild cognitive impairment due to Alzheimer’s disease (MCI due to AD) or mild AD.
- •4. Mini-Mental State Examination (MMSE) score ranging from 20 to 28, inclusive.
- •5. Evidence of amyloid pathology by Amyloid PET scan determined by visual inspection (any method) by an experienced nuclear medicine physician.
- •6. If the patient is taking drug for AD (e.g.; donepezil or memantine), he has been on a stable dose for at least 3 months.
- •7. Dutch-speaking.
- •8. Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Evidence of neurodegenerative disease other than AD (including but not limited to vascular dementia, dementia with Lewy bodies, and Parkinson’s disease).
- •2. Subject has any concurrent medical or psychiatric condition that, in the opinion of the investigator, would compromise his/her ability to comply with the study requirements.
- •3. History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.
- •4. 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.
- •5. History of an allergic reaction of any severity to 11PiB injection.
- •6. Subject participated in a study of an investigational drug less than 3 months or 5 half-lives of the investigation drug, whichever is longer, before enrollment in this study.
- •7. Male subjects with female partners of child-bearing potential who are unwilling or unable to adhere to contraception requirements.
- •8. Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingo-oophorectomy.
- •9. Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial.
- •10. Contraindications (e.g. pacemaker, vascular stent or stent graft) to MRI testing.
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