A Phase 2 Clinical Study to Explore the Optimal Dosage/Administration of PM012 Tablet in Alzheimer's Disease: Double-Blind, Randomized Between Placebo Control Group and Dose Groups, Parallel-Design, Multicenter Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 4
- 主要终点
- ADAS-cog
研究概览
简要总结
The investigators intend to perform exploratory evaluation of the treatment effectiveness and safety of PM012 Tablet of PuriMED Co., Ltd. at 2 doses in Korean patients with mild to moderate dementia of Alzheimer's type. To achieve this, this study aims to compare each dose with placebo control for the efficacy and safety to explore the clinically optimal dose of PM012 Tablet for therapeutic confirmatory (phase 3) clinical studies.
详细描述
- Period of study
-48 months from the date of KFDA approval of the protocol 2. Study subjects
-Patients with mild to moderate Alzheimer's disease 3. Study objectives
- Primary objective
- To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 12 post-dose
- Secondary objectives
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥ 50 and ≤ 85 years
- •Clinically diagnosed with probable Alzheimer's disease based on DSM-IV and NINCDS-ADRDA criteria
- •K-MMSE score of 12~26 at screening visit
- •For females: 2 years of confirmed menopause or surgical sterilization.
- •Able to walk (including the use of aids)
- •Able to perform procedures for cognitive and other tests
- •Residing with a life-long guardian willing to accompany the subject's on all visits, oversee his/her compliance with the procedures specified in the protocol and the study drug, and report his/her condition.
- •Having signed him/herself or his/her legally acceptable representative having signed the written informed consent form
排除标准
- •Possible, probable, or definite vascular dementia by NINDS-AIREN criteria
- •History and/or evidence (result of CT or MRI performed within the past 12 months or at screening) of other CNS disease (cerebrovascular disease, structural or developmental anomaly, epilepsy, contagious, degenerative or infectious/demyelinating CNS condition) as a cause of dementia
- •Delusion, delirium, epilepsy and other neurological pathology on neurological examination
- •Abnormal test result on vitamin B12, syphilis serology, and thyroid stimulating hormone (TSH) tests that are thought to contribute to the subject's dementia severity or be a cause of dementia
- •History of significant psychiatric disease such as schizophrenia or bipolar affective disorder that may interfere with the participation in this study in the opinion of the investigator, or current depression (GDS ≥ 18)
- •Past history of known or suspected seizures including febrile convulsion, unexplained recent unconsciousness or past history of significant head trauma with unconsciousness.
- •Gastrointestinal, endocrine and cardiovascular disease not controlled by diet or pharmacologic therapy
- •Cardiac disease such as myocardial infarction or valvular disease of heart, arrhythmia within 3 months of the study start
- •Diabetes mellitus not controlled by hypoglycemic agent or insulin-dependent diabetes mellitus
- •Past history of alcohol or other drug abuse
- •Having taken acetylcholinesterase inhibitor or memantine within the past 3 months
- •Hypertension with systolic blood pressure of > 165 mmHg or diastolic blood pressure of > 96 mmHg
- •Severe renal impairment (serum creatinine ≥ 1.7 mg/dl)
- •Severe hepatic impairment (ALT, AST, or bilirubin ≥ 2.0 x upper limit of normal)
- •Is taking or expected to take disallowed concomitant medication
- •History of clinically significant drug hypersensitivity
- •Is ineligible to participate in this study in the judgment of the investigator
研究组 & 干预措施
Placebo group
• Drug : Placebo 2 tablet
The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.
干预措施: Placebo (Drug)
Dose group 1
- Drug : Placebo 1 tablet + Study drug 1 tablet
- Study drug(650-mg PM012 tablet)
The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.
干预措施: PM012 (Drug)
Dose group 1
- Drug : Placebo 1 tablet + Study drug 1 tablet
- Study drug(650-mg PM012 tablet)
The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.
干预措施: Placebo (Drug)
Dose group 2
- Drug : Study drug 2 tablet
- Study drug (650-mg PM012 tablet)
The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.
干预措施: PM012 (Drug)
结局指标
主要结局
ADAS-cog
时间窗: Week 12 post-dose
\* To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 12 post-dose
次要结局
- ADAS-cog(Weeks 8 post-dose)
- CDR(Weeks 8 and 12 post-dose)
- K-IADL(Weeks 8 and 12 post-dose)
- NPI(Weeks 8 and 12 post-dose)
- K-MMSE(Weeks 8 and 12 post-dose)
- VAS(at Weeks 8 and 12 post-dose)
- AE(while the subject is receiving the treatment)