EUCTR2017-003728-64-GB进行中（未招募）1 期
A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized Study ToEvaluate the Efficacy, Safety and Tolerability of E2027 in Subjects WithDementia With Lewy Bodies
Eisai Ltd0 个研究点目标入组 260 人开始时间: 2018年7月19日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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. Male or female, age 50 to 85 years, inclusive at time of consent.
- •2. Meet criteria for probable DLB (as defined by the 4th report of the DLB Consortium) (Appendix 1). Specific situations regarding the use the imaging are described below:
- •a. have 1 core clinical feature only by the investigator and who did not have previous reports of DAT brain imaging scan, MIBG scan or polysomnography (PSG) will undertake DAT brain imaging scan or MIBG scan as organized by the investigator.
- •b. have 2 or more core clinical features by the investigator but who are judged as having only 1 core clinical feature by central reviewer and who did not have previous reports of DAT brain imaging scan, MIBG scan or PSG may undertake DAT brain imaging scan or MIBG scan after
- •discussion with the sponsor medical monitor.
- •c. have 2 or more core clinical features by the investigator and the XML File Identifier: tnzd80I4v1FKEXbCW5d92QgJdwI=Page 12/26 central reviewer and who did not have previous reports of DAT brain imaging scan, MIBG scan or PSG may undertake DAT brain imaging scan
- •or MIBG scan after discussion with the sponsor medical monitor if the investigator considers that imaging is necessary to confirm the diagnosis.
- •Where there are local/national regulatory requirements for additional central regulatory review of radiation exposure for the use of DAT /MIBG scans, enrollment of subjects is restricted to those who do not require a new DAT / MIBG scan conducted under this study (ie, subjects who have historical DAT/MIBG scan/PSG results, or subjects who have 2 core clinical features of DLB) until such approval is granted by the regulatory authority on radiation exposure. Thereafter enrollment of subjects will extend to those who may require a new DAT / MIBG scan under this study. (revised per Amendment 01).
- •3. MMSE >14 and <26 at Screening Visit.
- •4. Has experienced visual hallucinations during the past 4 weeks before Screening Visit.
- •5. If receiving AChEIs, must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment-naïve subjects can be entered into the study but there should be no plans to initiate treatment with AChEIs from
- •Screening to the end of the study.
- •6. If receiving memantine, must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naïve subjects can be entered into the study but there should be no plans to initiate treatment with memantine from Sreening to the end of the study. (revised per Amendment 03).
- •7. Must have an identified caregiver or informant who is willing and able to provide follow-up information on the subject throughout the course of the study. This person must, in the opinion
- •of the investigator, not be suffering from cognitive impairment, be sufficiently familiar with the subject and spend sufficient time with the subject on a regular basis such that the caregiver or
- •informant can reliably fulfill the study requirements and must provide separate written consent.
- •The caregiver or informant should normally be residing with the subject.
- •If the caregiver or informant is not residing with the subject, the investigator has to be satisfied that the subject can contact the caregiver or informant readily during the times when the caregiver or informant is not with the subject. As a guide the caregiver or informant should have
- •contact with the subject on at l
排除标准
- •1. Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the subject's DLB, including any comorbidities detected by clinical assessment or MRI.
- •2. History of transient ischemic attacks or stroke within 12 months of Screening.
- •3. Modified Hachinski Ischemic Scale >4.
- •4. Parkinsonian (extrapyramidal) features with Hoehn & Yahr stage IV or higher.
- •5. Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V).
- •6. GDS score >8.
- •7. Severe visual or hearing impairment that may interfere with the Subject study assessments including cognitive testing.
- •8. History of deep brain stimulation or other neurosurgical procedure for Parkinson's disease.
- •9. Have thyroid stimulating hormone (TSH) above normal range. Other tests of thyroid function with results outside the normal range should only be exclusionary if they are considered clinically significant by the investigator. This applies to all subjects whether or not they are
- •taking thyroid supplements.
- •10. Abnormally low serum Vitamin B12 levels (less than the lower limit of normal [LLN]) for the testing laboratory (if subject is taking Vitamin B12 injections, level should be at or above the LLN for the testing laboratory).
- •11. Contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic
- •metal implants (eg, in skull and cardiac devices other than those approved as safe for use in MRI scanners). Subjects who require sedation for MRI or positron emission tomography (PET)
- •scanning as per local guidelines need not be excluded.
- •12. Evidence of other clinically significant lesions that suggest a dementia diagnosis other than DLB on brain MRI at Screening. All MRIs will be acquired using a standardized procedure that will be outlined in the Imaging Charter and Imaging Acquisition Guidelines (IAG) and will
- •be read by an approved centralized reader.
- •13. Other significant pathological findings on brain MRI at Screening, including but not limited to:
- •any macrohemorrhage (greater than 10 mm at greatest diameter); an area of superficial siderosis; evidence of cerebral contusion, encephalomalacia, aneurysms, arteriovenous malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving
- •a major vascular territory, severe small vessel or white matter disease; space occupying lesions; or brain tumors [however, lesions diagnosed as meningiomas or arachnoid cysts and less
- •than or equal to 1 cm at their greatest diameter need not be exclusionary])
- •14. Hypersensitivity to E2027 or any of the excipients.
- •15. A prolonged corrected QT interval calculated using Fridericia's formula (QTcF) as demonstrated by triplicate ECG at the Screening or Baseline Visit (ie, mean value >450 msec).
- •16. Had symptomatic orthostatic hypotension or symptomatic orthostatic tachycardia which resulted in hospitalization or urgent medical review in hospital in the past 12 months before Screening.
- •17. Any other clinically significant abnormalities that in the opinion of the investigator, require further investigation or treatment or that may interfere with study procedures or safety in the
- •? Physical examination, ECG, vital signs at Screening or Baseline Visit
- •? Laboratory tests at Screening Visit
研究者
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