ISRCTN16105064已完成未知
The MADE Trial: Minocycline in Alzheimer's Disease Efficacy trial
King's College London (UK)0 个研究点目标入组 544 人开始时间: 2013年7月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 544
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31738372 (added 19/11/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diagnosis by National Institute on Aging (NIA)/ Alzheimer's Association (AA) criteria of possible or probable Alzheimer's Disease (McKhann et al 2011)
- •2. Standardized Mini-Mental State Examination (SMMSE) score >23 with no upper limit
- •3. Consenting to participate
- •Target Gender: Male & Female; Upper Age Limit 100 no age limit or unit specified ; Lower Age Limit 45 no age limit or unit specified
排除标准
- •1. Known allergy to tetracycline antibiotics
- •2. Diagnosis of mild cognitive impairment
- •3. Female of childbearing potential. Patients must be surgically sterile (hysterectomy, bilateral salpingectomy/oophorectomy) for at least 6 months minimum or have undergone bilateral tubal occlusion/ligation at least 6 months prior or have been post-menopausal for at least 1 year.
- •4. Pregnancy and lactation.
- •5. Known chronic kidney disease stages 3-5
- •6. Lacks capacity to give informed consent
- •7. Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator. Patients with creatinine clearance < 50 mL/min at Screening, according to the Cockcroft and Gault equation must be excluded.
- •8. Systemic Lupus Erythromatosis
- •9. Severe liver disease
- •10. Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days
- •Contraindications, warnings and special precautions to minocycline use are not described further in the protocol and the investigator should refer to the Summary of Product Characteristics http://emc.medicines.org.uk/.
研究者
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