EUCTR2014-002013-37-ES进行中（未招募）1 期
An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer?s Disease or Behavioral Variant Frontotemporal Dementia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
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. Subjects with a diagnosis according to NIA/AA criteria of all cause dementia and probable Alzheimer?s disease at enrollment and who completed participation in one of the following three TauRx studies (inclusive of the 4-week post-treatment follow-up visit): TRx-237-005, TRx-237-008, or TRx-237-015.
- •Subjects with a diagnosis of probable bvFTD according to the International Consensus Criteria for bvFTD at enrollment and who completed participation in TauRx study TRx-237-007 through Visit 9 (Week 52).
- •Treatment will not be made available to subjects who have withdrawn from the double-blind study of prior participation prior to completion.
- •2. Females of childbearing potential must continue to use adequate contraception defined as follows (or, if in Italy, agree to avoid pregnancy):
- •? Barrier method (such as condom, diaphragm or cervical/vault cap) with spermicidal foam, gel, film, cream, or suppository
- •? Intrauterine device [IUD] or system
- •? Oral or long-acting injected or implanted contraceptives for at least 3 months prior to Baseline
- •? Vasectomized partner (with the appropriate post-vasectomy documentation of the absence of spermatozoa in the ejaculate)
- •? True abstinence (when this is in line with the preferred and usual lifestyle of the subject)
- •Subjects must agree to continue to maintain adequate contraception throughout participation in the study.
- •3. Subject and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law and IRB/EC approval, is/are able to read, understand, and provide written informed consent in the designated language of the study site
- •? In Germany, subjects must be able to provide their own written informed consent.
- •4. Has an identified adult caregiver who meets the following criteria:
- •? Either lives with the subject or sees the subject on average for ? 1 hour/day ? 3 days/week, and in the investigator?s opinion, the extent of contact is sufficient to provide meaningful assessment of changes in subject behavior and function over time and provide information on safety and tolerability
- •? Is willing to provide written informed consent for his/her own participation
- •? Is able to read, understand, and speak the designated language at the study site
- •? Agrees to accompany the subject to each study visit
- •? Is able to verify daily compliance with study drug
- •5. Able to comply with the study procedures in the view of the investigator
- •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 1050
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 350
排除标准
- •1. History of swallowing difficulties (note: study drug should be swallowed whole and MUST NOT be broken, crushed or chewed or dissolved in fluids prior to ingestion)
- •2. Pregnant or breastfeeding
- •3. Clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in originating study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk of participation outweighing the potential benefit
- •4. Current participation in, or intent to enroll in, a clinical trial of a drug, biologic, device, or medical food
研究者
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