EUCTR2012-002847-28-ES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
- 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 0.5 or 1 (mild) and MMSE score of 22-26 (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 oophorectomy) for at least 6 months minimum
- •? Have undergone bilateral tubal ligation at least 6 months prior
- •? Post-menopausal for at least 1 year
- •? Using adequate contraception (such as condoms, foams, jellies, diaphragm, intrauterine device [IUD], oral or long-acting injected contraceptives for at least 3 months prior to Baseline or vasectomized partner) or true abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception); subjects must agree to continue to maintain adequate contraception throughout participation in the study
- •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
- •7. Has an identified caregiver who meets the following criteria:
- •? Either lives with the subject or sees the subject on average for ? 2 hours/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
- •8. If currently taking an acetylcholinesterase inhibitor (AChEI), i.e., donepezil, galantamine, or rivastigmine, and/or memantine:
- •? 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 before Baseline (Visit 2)
- •? 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 Baseline) 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 subjects for this age range 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 270
排除标准
- •1.Significant CNS disorder other than Alzheimer?s disease
- •2.Significant intracranial focal or vascular pathology seen on brain MRI scan within a maximum of 28 days before Baseline that would lead to a diagnosis other than probable Alzheimer?s disease or that puts the subject at risk of ARIA, including: other focal brain lesions, 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, substance (including alcohol) related disorders (within the past 5 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.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
- •?G6PD deficiency
- •?Baseline value below age/sex appropriate lower limit of the central laboratory normal range for any of the following:
- •oHemoglobin (subject may be treated and re-screened after 3 months)
- •oVitamin B12 or folate (subject may be treated and re-screened after 3 months)
- •11.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 re-screened after 3 months)
- •12.Clinically significant cardiovascular disease or abnormal assessments such as:
- •?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 atrial fibrillation on ECG or history of atrial fibrillation that is not currently controlled
- •?QTcB at Screening or Baseline >450 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 Screening or at Baseline
- •?Hypotension: systolic blood pressure <100 mmHg at Screening or at Baseline
- •?Heart rate <48 bpm or >96 bpm by measurement of vital signs or by ECG at Screening or at Baseline
- •13.Preexisting or current signs or symptoms of respiratory failure; in addition, subjects should be excluded if they have: previously diagnosed moderate to severe sleep apnea not adequately controlled
- •14.Concurrent acute or
研究者
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