EUCTR2012-002847-28-DE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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •Probable Alzheimer's disease
- •2. Clinical Dementia Rating (CDR) total score of 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
- •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
- •post-vasectomy 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
- •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, subjects must be able to provide their own written
- •informed consent
- •7. Has one or more identified adult caregivers who meet the following
- •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
- •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
- •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
- 另有 11 项未显示
排除标准
- •1.Significant CNS disorder other than AD
- •2.Significant intracranial focal or vascular pathology seen on brain MRI scan within a maximum of 42 days before Baseline that would lead to a diagnosis other than probable AD or that puts the subject at risk of ARIA, including: 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 years)
- •Transient ischemic attack(6 months)
- •Significant head injury with associated loss of consciousness, skull fracture or persisting cognitive impairment (2 years)
- •Other unexplained or recurrent loss of consciousness =15 minutes (2 years)
- •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 years), or substance (including alcohol) related disorders (within the past 2 years)
- •6.Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MR imaging; MR compatible prosthetics, clips, stents, or any other device proven to be compatible will be allowed.
- •7.Resides in hospital or moderate to high dependency continuous care facility
- •8.History of swallowing difficulties
- •9.Pregnant or 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 laboratory normal range
- •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 laboratory
- •normal range (subject may be treated and rescreened after 3 months)
- •13.Clinically significant cardiovascular disease or abnormal assessments
- •Hospitalization for acute coronary syndrome or symptoms consistent
- •with angina pectoris, within the 12 months preceding Baseline
- •Signs or symptoms of clinical heart failure within the 12 months
- •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
- •Heart rate <48 bpm or >96 bpm by measurement of vital signs or by
- •ECG at Screening
- •14.Preexisting or current signs or symptoms of respiratory failure.
- •Subjects with previously diagnosed moderate to severe sleep apnea not
- •adequately controlled should be excluded.
- •15.Concurrent acute or chronic clinically significant immunologic,
- •hepatic, or endocr
研究者
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