NCT02185053已完成2 期
A Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients With Alzheimer's Disease Type Dementia
Chase Pharmaceuticals Corporation, an affiliate of Allergan plc1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2014年7月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Donepezil Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with Alzheimer's Disease Type Dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50 - 79 years inclusive.
- •Meeting the diagnosis of probable Alzheimer's Disease
- •Of moderate severity (Mini-Mental Status Exam [MMSE] score 10 - 20 inclusive).
- •Patients must be in generally good health as indicated by their medical history and physical examination, vital signs, electrocardiogram (ECG), and standard laboratory tests.
排除标准
- •Women of child bearing potential.
- •History or presence of a seizure disorder.
- •History of peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease.
- •History or presence of bladder outflow obstruction, gastrointestinal obstructive disorder or reduced GI motility, or narrow-angle glaucoma.
- •History or presence of gastrointestinal, hepatic, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •History or presence of myasthenia.
- •Known hypersensitivity to donepezil, solifenacin or related drugs.
- •Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
- •Patients who have participated in another clinical trial with an investigational drug within previous 30 days.
研究组 & 干预措施
CPC-201
Experimental
干预措施: CPC-201 (Drug)
结局指标
主要结局
Donepezil Maximum Tolerated Dose (MTD)
时间窗: 6 months
Number of participants who reached Donepezil Maximum Tolerated Dose of 40 mg/day (highest allowed per protocol) at the end of donepezil dose titration phase and at the end of the maintenance phase.
次要结局
- Number of Subjects With Any TEAEs(6 months)
- Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose(Day 1 (baseline) to end of study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's DiseaseParkinson DiseaseNCT03257046Intra-Cellular Therapies, Inc.40
终止
2 期
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 in Duchenne Muscular DystrophyDuchenne Muscular DystrophyNCT02310763Pfizer121
已完成
1 期
Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 IllnessCOVID-19NCT05298813Immune Biosolutions Inc162
撤回
2 期
Study of F-652 in Subjects With Corona Virus Disease 2019 (COVID-19) PneumoniaCOVID-19 PneumoniaNCT05205668EVIVE Biotechnology
Unknown
1 期
A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine STR-V003 in Healthy AdultsRespiratory Syncytial Virus InfectionsNCT06344975Starna Therapeutics48