EUCTR2013-002653-30-IT进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26-Week, Phase 3 Study of Two Doses of EVP-6124 or Placebo in Subjects with Mild to Moderate Alzheimer’s Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication
EnVivo Pharmaceuticals, Inc.0 个研究点目标入组 790 人开始时间: 2013年12月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 790
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
- •Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
- •1. Informed consent form (ICF) signed by the subject or legally acceptable representative before any study-specific procedures for the subject are performed and an ICF signed by the support person/caregiver before any study-specific procedures for the support person/caregiver are performed.
- •2. Male or female subjects of any race, aged =55 and =85 years
- •3. Clinical diagnosis of dementia due to probable AD consistent with criteria established by a workgroup of the National Institute on Aging and the Alzheimer’s Disease Association (McKhann et al, 2011)
- •4. Clinical decline within 12 months before screening and onset of symptoms at least 12 months or longer before screening, which may include any documented cognition, functional, or other objective assessment or the clinical judgment of the investigator or the subject’s referring physician that the subject has experienced a clinical decline within the last 12 months
- •5. Magnetic resonance imaging (MRI) or computed tomography (CT) scan performed within 12 months before screening, with findings consistent with the diagnosis of dementia due to AD without any other clinically significant comorbid pathologies. If an MRI or CT scan is unavailable or occurred greater than 12 months before screening, this assessment should be completed and the findings confirmed before the subject enters the run-in period (Day -14) (copy of the report will be available at the study site)
- •6. Mini-Mental State Examination (MMSE) score =14 and =24 at screening and confirmed on Day 1 prior to randomization (fluctuations of ±2 points are acceptable on Day 1/baseline)
- •7. Clinical Dementia Rating Global score (CDR-GS) =1 (at least mild dementia) at screening and confirmed on Day 1 prior to randomization
- •8. Modified Hachinski Ischemic Scale (mHIS) score =4 at screening
- •9. Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception.
- •10. Reliable and capable support person/caregiver, who if not living in the same household, interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible.
- •11. Subject living at home, senior residential setting, or an institutional setting without the need for continuous (ie, 24-hour) nursing care.
- •12. General health status acceptable for participation in a 26-week study
- •13. Fluency (oral and written) in the language in which the standardized tests will be administered
- •14. Receiving a stable dose of an AChEI (donepezil, rivastigmine or galantamine) for at least 3 months (90 days) before screening and with continuous dosing for at least 6 months OR not presently receiving an AChEI (at least 30 days before screening), but with a history of previous AChEI treatment (subjects receiving donepezil 23 mg currently or within 3 months before screening are ineligible)
- •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 79
- •F.1.3 Elderly (>=65 years) yes
排除标准
- •Subjects who meet any of the following exclusion criteria will be excluded from participating in the study:
- •Exclusion Criteria - General
- •1. Exposure to an experimental drug, experimental biologic or experimental medical device within 2 months (60 days) before screening
- •2. Prior participation in an amyloid vaccination clinical study at any time in the past or completion of a passive amyloid vaccination study within 6 months before screening
- •3. Inability to swallow a tablet
- •4. In the judgment of the investigator, inability of the subject or the support person/caregiver to complete a 26-week study
- •5. Inability to be =75% compliant with single-blind study drug
- •6. Inability to adequately cooperate or complete the cognitive testing procedures or any study assessment
- •7. Residence in a skilled nursing facility
- •Exclusion Criteria - Medical
- •8. Untreated vitamin B12 or folate deficiency (if treated, must be stably treated for at least 6 months before screening)
- •9. Clinically significant (in the judgment of the investigator) abnormal serum electrolytes (sodium, potassium, magnesium) after repeat testing
- •10. Clinically significant untreated hypothyroidism (if treated, thyroid-stimulating hormone level and thyroid supplementation dose must be stable for at least 6 months before screening)
- •11. Insufficiently controlled diabetes mellitus (in the judgment of the investigator) or requiring insulin
- •12. Renal insufficiency (serum creatinine >2.0 mg/dL)
- •13. Malignant tumor within 3 years before screening (except squamous and basal cell carcinoma or cervical carcinoma in situ or brachytherapy for localized prostate cancer)
- •14. Unstable medical condition that is clinically significant in the judgment of the investigator
- •15. Female subjects who are pregnant, nursing, or planning to become pregnant during the study
- •16. Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times the upper limit of normal
- •Exclusion Criteria - Cardiovascular
- •17. History of myocardial infarction or unstable angina within 6 months before screening
- •18. History of more than 1 myocardial infarction within 5 years before screening
- •19. Clinically significant (in judgment of the investigator) cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (subjects with a pacemaker are acceptable)
- •20. Symptomatic hypotension or hypertension (supine diastolic blood pressure >95 mmHg) (in the judgment of the investigator)
- •21. Clinically significant abnormality on screening or baseline ECG, including but not necessarily limited to a confirmed QTc value =450 msec for males or =470 msec for females
- •Exclusion Criteria - Psychiatric
- •22. Diagnosis of severe major depressive disorder with psychotic features, delusions or hallucinations, which is either recurrent (Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision [DSM-IV-TR] 296.34) or single episode (DSM-IV-TR 296.24) within 5 years before screening (American Psychiatric Association, 2000)
- •23. Geriatric Depression Scale (GDS) score (15-item scale) >5 at screening or baseline
- •24. History or current diagnosis of psychosis (American Psychiatric Association, 2000)
- •25. History within 2 years before screening or current evidence of substance abuse as defined by the DSM-IV-TR
- •26. Significant suicide risk as defined by 1) suicidal ideation as endorsed on items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS
研究者
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