EUCTR2016-003928-23-GB进行中（未招募）1 期
A Placebo-Controlled, Double-Blind, Parallel-Group, 24-Month Study with an Open-Label Extension Phase to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer’s Disease
Eisai Ltd.0 个研究点目标入组 950 人开始时间: 2017年2月23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
- 950
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. MCI due to Alzheimer’s disease or Mild Alzheimer’s disease according to the NIA-AA core clinical criteria and must have all of the following at screening:
- •a. MMSE score equal to or greater than 24
- •b. CDR global score of 0.5
- •c. CDR Memory Box score of 0.5 or greater
- •2. A history of subjective memory decline with gradual onset and slow progression over the last 1 year before Screening; this MUST be corroborated by a study partner
- •3. Cognitive impairment of at least 1 SD from age-adjusted norms in total recall or delayed recall on the ISLT.
- •4. Positive biomarker for brain amyloid pathology as indicated by at least 1 of the following:
- •a. PET assessment of amyloid imaging agent uptake into brain. Note: Amyloid PET screens will be performed according to local regulatory guidelines and thus may be restricted for those subjects who are not suitable for lumbar puncture (LP) to obtain CSF for testing of eligibility.
- •b. CSF AD assessment (eg. Aß(1-42), tau: Aß(1-42) ratio) NOTE: Subjects may undergo both the Amyloid PET and CSF assessments, but need a positive amyloid result in only 1 of the 2 procedures to confirm eligibility. Subjects who consent to Amyloid PET or CSF for eligibility purposes are not required to participate in the Amyloid PET or CSF longitudinal substudies. Use of a historical amyloid positive PET (conducted within 12 months before the planned date of randomization) is acceptable for determination of eligibility but will not suffice for the baseline assessment if the subject wishes to consent to the Amyloid PET longitudinal substudy. The historical imaging data must be made available to the sponsor. The historical imaging data must be made available to the sponsor. Historical CSF samples, if collected, processed, and stored under appropriate conditions and approved by the sponsor, may be analyzed to determine CSF amyloid positivity.
- •5. Male or female subjects between 50 and 85 years of age, inclusive at the time of consent
- •6. If receiving an AChEI or memantine or both for AD, must be on a stable dose for at least 12 weeks prior to Randomization. Treatment-naïve subjects with AD can be entered into the study.
- •7. Subjects must have been on stable doses of all other (ie, non-AD related) permitted concomitant medications for at least 4 weeks prior to Randomization, except for medications which are administered as short courses (eg, up to 3 weeks unless discussed and agreed with Medical Monitor) of treatment (eg, anti-infectives) or which are to be used on a Pro re nata (PRN) basis. Subjects who require a short course of treatment, such as an anti-infective, may be randomized once the acute illness has completely resolved, even if the concomitant medication continues.
- •8. Must have an identified study partner (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject). The study partner must be literate and able to provide written informed consent. In addition, this person must be 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, spend sufficient time with the subject on a regular basis such that they can reliably fulfill the requirements of being a study partner. A study partner need not be living in the same residence with the subject. For such a study partner not residing with the subject, the investigator has to be satisfied that the subject
排除标准
- •1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive
- •beta-human chorionic gonadotropin test. A separate baseline assessment is required if a negative
- •screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- •Females of child-bearing potential who:
- •Within 28 days before study entry, did not use a highly effective method of contraception,
- •which includes any of the following:
- •o total abstinence (if it is their preferred and usual lifestyle)
- •o an intrauterine device or intrauterine hormone-releasing system
- •o an oral contraceptive (Subject must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation.)
- •o have a vasectomized partner with confirmed azoospermia.
- •Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation.
- •For sites outside of the European Union, it is permissible that if a highly effective method of
- •contraception is not appropriate or acceptable to the subject, then the subject must agree to use a
- •medically acceptable method of contraception, ie, double-barrier methods of contraception such
- •as condom plus diaphragm or cervical/vault cap with spermicide.
- •NOTE: All females will be considered to be of child-bearing potential unless they are
- •postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group,
- •and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal
- •ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before
- •2. Any condition that may be contributing to cognitive impairment above and beyond that caused by
- •the subject’s AD
- •3. Subjects with a history of seizures within 5 years of Screening or subjects with disturbance likely
- •to be due to seizures within 5 years of Screening
- •4. History of transient ischemic attacks (TIA) or stroke within 12 months of Screening
- •5. Modified Hachinski Ischemia Score greater than 4 at Screening
- •6. Any of the following psychiatric symptoms:
- •Psychiatric diagnosis or symptoms, (eg, hallucinations, major depression, or delusions) that, in the opinion of the investigator, could interfere with study procedures
- •Has a yes” answer to C-SSRS suicidal ideation items 4 or 5, or any suicidal behavior within 6 months before Screening, at Screening, or at the Randomization Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening
- •7. Have any 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) or
- •Have any evidence of other clinically significant lesions that could indicate a dementia
- •diagnosis other than AD on brain MRI at Screening.
- •Exhibit other significant pathological findings on central read of the brain MRI at Screening, including but not limited to: an area of superficial siderosis; evidence of cerebral vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of multiple lacunar infarcts; evidence of stroke involving a major vascular territory; severe small vessel, or diffuse matter disease as defined by a score of 3
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