EUCTR2012-002847-28-FI进行中（未招募）1 期
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Mild Alzheimer’s Disease - TRx-237-005
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
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. Diagnosis according to the National Institute on Aging (NIA) and Alzheimer's Association (AA) criteria of:
- •All cause dementia and
- •Probable Alzheimer's disease
- •2. Clinical Dementia Rating (CDR) total score of 0.5 or 1 (mild) and MMSE score of 20-26 (inclusive) at Screening
- •3. Age <90 years at Screening
- •4. Modified Hachinski ischemic score of =4 at Screening
- •5. Females must meet one of the following:
- •Surgically sterile (hysterectomy, bilateral salpingectomy/oophorectomy) for at least 6 months minimum
- •Have undergone bilateral tubal occlusion/ligation at least 6 months prior
- •Post-menopausal for at least 1 year
- •Using adequate contraception (a barrier method [such as condom, diaphragm or cervical/vault cap] with spermicidal foam, gel, film, cream, or suppository; intrauterine device [IUD] or system, or oral or longacting injected or implanted hormonal contraceptives for at least 3 months prior to Baseline; or vasectomized partner [with the appropriate postvasectomy documentation of the absence of spermatozoa in the ejaculate]) or true abstinence (when this is in line with the preferred and usual lifestyle of the subject); subjects must be competent to use adequate contraception and to agree to continue to maintain adequate contraception throughout participation in the study OR In Italy, have avoided a pregnancy for at least 3 months prior to Baselineand accept to avoid a pregnancy throughout participation in the study
- •OR In Italy, have avoided a pregnancy for at least 3 months prior to
- •Baseline and accept to avoid a pregnancy throughout participation in the
- •6. Subject and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law, is/are able to read, understand, and provide written informed consent in the designated language of the study site
- •In Germany, subject must be able to provide their own written informed consent
- •7. Has one or more identified adult caregivers who meet the following criteria:
- •• Either lives with the subject or sees the subject on average for = 2
- •hours/day = 3 days/week, or 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
- •8. If currently taking an acetylcholinesterase inhibitor (AChEI), i.e., donepezil, galantamine, or rivastigmine, and/or memantine at the time of Screening:
- •The subject must have been taking such medication(s) for = 3 months
- •The current dosage regimen and dosage form must be within the locally approved dose range and must have remained stable for = 6 weeks
- •It must be planned that the dosage regimen will remain stable throughout participation in the study
- •Subjects not being treated with an AChEI or memantine (for = 6 weeks before Screening) may also be enrolled if initiation of an AChEI or memantine is not planned for the time period during which the subject will be participating in this study
- •9. 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 subjec
排除标准
- •1.Significant CNS disorder other than AD 2.Significant intracranial focal or vascular pathology seen brain MRI scan
- •within 42 days before Baseline that would lead to a diagnosis other than
- •AD or that puts the subject at risk of ARIA, inc: large confluent white
- •matter hyperintense lesions, other focal brain lesion(s), a single area of
- •superficial siderosis, >4 cerebral microhemorrhages, evidence of a prior
- •macrohemorrhage
- •3.Clinical evidence or history of any of the following within specified
- •period prior to Baseline:
- •Cerebrovascular accident (2 yrs) •Transient ischemic attack (6 mnths)
- •Significant head injury with associated loss of consciousness, skull
- •fracture or persisting cognitive impairment (2 yrs)
- •Other unexplained or recurrent loss of consciousness =15 minutes
- •4.Epilepsy (a single prior seizure is considered acceptable)
- •5.DSM IV-TR criteria met for any of the following within specified period:
- •Major depressive disorder (current)
- •Schizophrenia (lifetime)
- •Other psychotic disorders, bipolar disorder (within the past 5 yrs), or
- •substance (inc alcohol) related disorders (within past 2 yrs)
- •6.Metal implants in the head (ex dental), pacemaker, cochlear implants,
- •or other non-removable items that are contraindications to MRI; MR
- •compatible prosthetics, clips, stents, or other device proven compatible
- •will be allowed.
- •7.Resides in hospital or moderate - high dependency continuous care
- •8.swallowing difficulties
- •9.Pregnant /breastfeeding
- •10.G6PD deficiency 11.History of significant hematological abnormality or current acute or
- •chronic clinically significant abnormality, including:
- •History of hereditary or acquired methemoglobinemia or baseline
- •measurement of MetHb >2.0%
- •History of hemoglobinopathy, myelodysplastic syndrome, hemolytic
- •anemia, or splenectomy
- •Screening hemoglobin value below age/sex appropriate lower limit of
- •the central lab normal range for any of the following:
- •oHemoglobin(subject may be treated and re-screened)
- •oVitamin B12 or folate (subject may be treated and re-screened after 3
- •mths)12.Abnormal serum chemistry laboratory value at Screening. In addition,
- •subjects with either of the following abnormalities must be excluded:
- •creatinine clearance <30 mL/min at Screening, TSH above lab normal
- •range (subject may be treated and re-screened after 3 mths)13.Clinically significant cardiovascular disease or abnormal assessments
- •Hospitalization for acute coronary syndrome or symptoms consistent
- •with angina pectoris, within the 12 mths preceding Baseline
- •Signs or symptoms of clinical heart failure within the 12 mths
- •preceding Baseline
- •Evidence of uncontrolled atrial fibrillation on Screening ECG or history
- •of atrial fibrillation that is not currently controlled or where the QT
- •interval cannot be assessed by triplicate ECGs
- •QTcF at Screening >460 msec in males or >470 msec in females, or low
- •or flat T waves making measurement of QT interval unreliable •Recent history of poorly controlled hypertension, systolic blood
- •pressure >160 mmHg, or diastolic blood pressure >100 mmHg, at
- •Hypotension: systolic blood pressure <100 mmHg at Screening
- 另有 7 项未显示
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