EUCTR2005-005915-13-GB进行中（未招募）1 期
An Open Pilot Study of Methlythioninium Chloride (MTC) in Frontotemporal Dementia and Related Dementia Syndromes - Pilot Stidy of MTC in FTD and related dementia syndromes
TauRx Therapeutics PTE Ltd0 个研究点目标入组 20 人开始时间: 2006年4月10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
- 入组人数
- 20
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.Patients of either sex supervised by a carer competent and willing to ensure compliance with medication and who is willing to participate in completing the various assessments.
- •2.Female patients should not be pregnant at the start of the study or planning a pregnancy during the course of the study.
- •3.Patients must be able to either give written informed consent to participation in the study, with additional assent to their participation being provided by a competent carer.
- •4.Patients must meet either:
- •Consensus Clinical Diagnostic Criteria for Frontotemporal Lobar Degeneration (Neary et al 1998) including MRI and HMPAO SPECT imaging consistent with the diagnosis
- •NINDS –SPSP Clinical Criteria for Diagnosis of Probable Progressive Supranuclear Palsy including MRI and HMPAO SPECT imaging consistent with that diagnosis (Litvan et al 1996a)
- •Diagnostic Criteria for Corticobasal Degeneration including MRI and HMPAO SPECT consistent with the diagnosis (Boeve et al 2003)
- •In addition to meeting the above criteria patients additionally must have significant cognitive impairment with a CAMCOG score of < 85.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The patient is not eligible to participate in the study in any of the following circumstances:
- •1.The patient has a known sensitivity to MTC or similar agents.
- •2.The patient has known glucose-6-phosphate dehydrogenase deficiency.
- •3.The patient has known hereditary methaemoglobinaemia, has been known to have suffered an attack of acquired methaemoglobinaemia or has a blood level of methaemoglobin at screening which is above the upper limit of normal for age and laboratory.
- •4.The patient has significant impairment of renal, hepatic or haematological function for the age of the patient.
- •5.The patient has started taking prescribed medication known to have an effect on mood, cognition or motor function within the previous six weeks or has changed the dose of such medication within the same period (e.g.cholinesterase inhibitors, memantine, anticholinergics, hypnotics, sedatives, anxiolytics, neuroleptics antidepressants, antiepileptics or antiparkinsonian drugs).
- •6.The patient has started taking an alternative anti dementia therapy (e.g. ginkgo biloba or HRT) within six weeks or has changed their dose within that period.
- •7. The patient is receiving warfarin or digitalis or any other medication that has a narrow margin between effective dose and toxic dose or between effective dose and ineffective dose, where the subject would be at risk if the levels were to rise or fall due to interaction with MTC.
- •8.Patients who are unlikely to comply with the study procedures or with study medication.
- •9.Patients with significant intercurrent illness which in the opinion of the investigator may compromise either the safety of the patient or the validity of the data.
- •10.Females who, in the opinion of the investigator, have the potential of childbearing and are not using adequate contraception or females who are breastfeeding.
- •11.Patients with a history of alcohol or drug abuse defined as meeting DSM-IV criteria for substance dependence. This applies to alcohol and /or any illicit drug including cannabis within the last six months.
- •12.The patient has participated in a clinical investigation of a medication or device within the previous three months.
研究者
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