EUCTR2013-001724-19-AT进行中（未招募）1 期
Pilot study to assess P-glycoprotein function at the blood-brain barrier of patients with mild to moderate Alzheimer's disease - Pgp_TQD_Alzheimer
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie0 个研究点开始时间: 2014年3月19日最近更新:
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
- •signed informed consent
- •age: =18 years old
- •physical examination and laboratory analysis: no presence of clinically relevant abnormal findings or values which the investigator considers may interfere with the objectives of the present study
- •no diseases, which the investigator considers may affect the outcome of the study
- •ability to comprehend the full nature and purpose of the study, including possible risks and side effects
- •Patient group (additionally):
- •Diagnosis of probable Alzheimer’s disease based on the NINCDS/ADRDA criteria . The severity of AD in a range from mild to moderate, which is in accordance with a MMSE score =12 and =26. The Hachinski score must be <4
- •A person who takes care of the patient must agree to accompany the subject to all study procedures
- •MRI must support AD diagnosis
- •Preferably 11C-PIB® positive scan
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Unwillingness to sign the informed consent
- •age:<18 years old
- •any abnormality found as part of the pre-treatment screening or in any of the laboratory tests performed that the investigators considers to interfere with the objectives of the present study or
- •any medication during two weeks before the start of the study, which the investigator considers may affect the validity of the study, due to interference with CYP3A4, Pgp or BCRP (Pgp inductors such as St. John’s wort, rifampicin or inhibitors such as esomeprazole, omeprazole, pantoprazole, lansoprazole, atrovastatin, itraconazole) or may cause potential harm to the subject (e.g. drug-drug interaction between tariquidar and loperamide or quinidine)
- •any disease which the investigator considers may affect the outcome of the study
- •participation in the evaluation of any drug within four weeks before the start of the study or participation in studies with radiation within 1 year before the start of the study
- •inability to comprehend the full nature and purpose of the study
- •contraindication for MRI imaging e.g. claustrophobia, metallic endoprosthesis, stent implantation in the last months
- •actual vitamin B12 and folic acid deficiency or history of craniocerebral injury
- •history of drug or alcohol abuse
- •Participation in clinical studies with exposure to radiation exceeding the allowed maximum foreseen by the current guidelines (http://ec.europa.eu/energy/nuclear/radioprotection/publication/doc/136_en.pdf
- •Patient group (additionally): AD patients with concomitant delirium
- •patients with Hachinski score >4, MMSE score out of the range of =12 and =26
- •patients and/or caregiver with probable compliance problems
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