NCT02860065撤回2 期
Phase II, Modified Single-Blind, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Cerebral Efficacy of CPC-201 in Patients With Alzheimer's Disease Type Dementia: PET Study
Chase Pharmaceuticals Corporation, an affiliate of Allergan plc1 个研究点 分布在 1 个国家开始时间: 2016年9月30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
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Donepezil Maximum tolerated dose (MTD) change on imaging
研究概览
简要总结
The purpose of this study is to compare the effect of low and high dose CPC-201 on brain function including cerebral acetylcholinesterase (AChE) activity measured by positron emission tomography (PET).
详细描述
Patients will continue on the 10 mg/day dose of donepezil with the addition of 15 mg/day of solifenacin at least for a week, donepezil will be titrated from 10 to 50 mg/day (maximum allowed dose; MAD) or each patient's MTD with increments of 5 or 10 mg weekly or bi-weekly as medically appropriate. When the MTD or MAD of donepezil co-administered with solifenacin 15 mg/day as CPC-201 has been reached, treatment will be stably maintained, as tolerated, for 3 months.
Patients successfully completing this protocol will have the option of continuing in an open extension of their CPC-201 treatment (separate protocol) or returned to their pre-admission therapeutic regimen and discharged from the study.
On the days of study drug dose increase, patients will be evaluated at a clinic as an out-patient.
This is a sequential study conducted in 6 phases in AD patients who had previously been receiving donepezil at a dose of 10 mg/day:
- Screening
- Baseline assessment
- Solifenacin introduction at a dose of 15 mg/day (given with continued donepezil 10 mg/day as CPC-201);
- Donepezil dose escalation to each subject's MTD or 50 mg/day (MAD), given in combination with solifenacin 15 mg/day as CPC-201;
- Donepezil maintenance at its MTD (or MAD) combined with solifenacin 15 mg/day as CPC-201 for 3 months;
- Protocol exit (after resumption of pre-study treatment regimen and successful completion of a one month post-study safety check) or optional entry into a 6 month extension phase.
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
- •Signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study protocol and are willing to participate in the study and comply with all its procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating screening procedures to evaluate their eligibility for the study.
- •Aged 50 - 79 years inclusive.
- •Meet the diagnosis of probable AD consistent with:
- •Revised National Institute on Aging-Alzheimer's Association (NIA-ADA) criteria and
- •Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria.
- •Of mild to moderate severity: Mini-Mental Status Exam (MMSE) score 10 - 24 inclusive.
- •Rosen-Modified Hachinski Ischemia Score of ≤
- •Have a suitable caregiver to supervise the at-home administration of study drugs and observe for AEs.
- •Treated with donepezil 10 mg/day (given once daily) for at least 4 weeks just prior to study entry and to have safely tolerated, as judged clinically by the investigator.
- •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 uncontrolled peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease.
- •History or presence of uncontrolled bladder outflow obstruction, gastrointestinal obstructive disorder or reduced gastrointestinal motility, or narrow-angle glaucoma.
- •Renal and hepatic dysfunction with:
- •Total Bilirubin: >1.5 x UNL
- •AST: >2.5 x UNL
- •ALT: >2.5 x UNL
- •Serum Creatinine: >1.5 x UNL
- •Creatinine Clearance: <30 mL/min (calculated by Cockcroft and Gault equation)
- •History or presence of myasthenia.
- •History of Prolonged QT Syndrome.
- •History of unexplained syncope.
- •Myocardial infarction or hospitalization for congestive heart failure within 6 months.
- •Patients has implanted cardiac pacemaker, implantable cardiac defibrillator (ICD), or metallic objects located in the eye, neck, ear, brain or blood vessel walls.
- •ECG findings of:
- •Complete Left Bundle Branch block;
- •Ventricular pacing;
- •2nd degree or 3rd degree AV block;
- •Atrial fibrillation or atrial flutter;
- •Heart rate <45 or >100;
- •PR >220 msec; or
- •QTcF >450 msec in male, >470 msec in female
- •Patients treated with the following medications within 8 weeks of screening
- •AChEIs (other than donepezil),
- •Peripherally acting anticholinergics (such as drugs for the treatment of overactive bladder disorder),
- •Psychoactive medications (including antipsychotics, antidepressants, anxiolytics or sedative hypnotics) having significant anticholinergic effects and/or believed to affect cognitive function.
- •Other medications are acceptable, at the investigators discretion, if dosage is held stable for at least 4 weeks prior to screening and throughout the study.
- •Claustrophobia
- •Patients considered unlikely to cooperate in the study, and/or poor compliance anticipated by the investigator.
- •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
combination of solifenacin and high doses of donepezil
干预措施: CPC-201 (Drug)
CPC-201
Experimental
combination of solifenacin and high doses of donepezil
干预措施: Positron emission tomography (PET) (Other)
结局指标
主要结局
Donepezil Maximum tolerated dose (MTD) change on imaging
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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