Minocycline in Alzheimer's disease efficacy trial:The MADE trial - MADE

King's College London0 个研究点目标入组 544 人开始时间: 2013年6月25日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•Diagnosis of possible or probable AD by NIA/AA criteria (McKhann et al 2011).
•sMMSE score >23 with no upper limit.
•Giving informed consent to participate.
•Aged 50+
•Participants must have a potential informant who will assist in the administration of the BADLS
•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 560
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 560

•Known allergy to tetracycline antibiotics.
•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.
•Uncontrolled serious concomitant illness
•Known chronic kidney disease stages 3b-5
•Moderate liver disease (see Child-Pugh for Classification of Severity of Liver Disease)
•Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator.
•Withholds consent for the study team to inform his/her GP
•Systemic Lupus Erythromatosus (SLE).
•Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days.

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