NCT02004392终止3 期
A 26-Week Extension Study of the Safety and Clinical Effects of EVP-6124 in Subjects With Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 348
- 主要终点
- Safety of 2 fixed doses of EVP-6124 for up to 52 weeks in subjects with Alzheimer's disease who complete study EVP-6124-024 or EVP-6124-025
研究概览
简要总结
This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive EVP-6124 for an additional 26 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects of any race, aged ≥55 and ≤85 years at time of entry into study EVP-6124-024 or EVP-6124-025
- •Informed consent form (ICF) for this extension study signed by the subject or legally acceptable representative and an ICF signed by the support person/caregiver before initiation of any study-specific procedures
- •Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025
- •No clinically significant change in the judgment of the investigator in the subject's medical status during study EVP-6124-024 or EVP-6124-025
- •In the judgment of the investigator, extension treatment is in the best interest of the subject
- •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 [including at least 1 barrier method])
- •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
排除标准
- •Significant risk of suicidal or violent behavior in the judgment of the investigator
- •Adverse events from the previous study (EVP-6124-024 or EVP-6124-025) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation
- •Any condition that would make the subject in the judgment of the investigator unsuitable for the study
- •Female subjects who are pregnant, nursing, or planning to become pregnant during the extension study
研究组 & 干预措施
EVP-6124, low dose
Experimental
low dose, Tablet, Once Daily, Day 1 through Day 182
干预措施: EVP-6124 (Drug)
EVP-6124, high dose
Experimental
high dose, Tablet, Once Daily, Day 1 through Day 182
干预措施: EVP-6124 (Drug)
结局指标
主要结局
Safety of 2 fixed doses of EVP-6124 for up to 52 weeks in subjects with Alzheimer's disease who complete study EVP-6124-024 or EVP-6124-025
时间窗: Baseline to Day 182 or Early Termination
Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, physical examination, concomitant medications, C-SSRS, and GDS.
次要结局
- Change from Baseline in cognition using the Mini-Mental State Examination (MMSE)(Baseline to Day 182 or Early Termination)
- Change from Baseline in quality of life using the EuroQol-5D (EQ-5D)(Baseline to Day 182 or Early Termination)
- Change from Baseline in psychiatric and behavioral symptoms using the Neuropsychiatric Inventory (NPI)(Baseline to Day 182 or Early Termination)
- Pharmacoeconomic outcomes using the Resource Utilization in Dementia (RUD-Lite 3.3)(Baseline to Day 182 or Early Termination)
- Caregiver perceived burden using the Zarit Burden Interview (ZBI)(Baseline to Day 182 or Early Termination)
研究者
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