A 12-Week Randomized, Double-blind, Parallel-group, Placebo-controlled Trial With and Open-label, 12-week Extension, Multicenter to Evaluation of the Efficacy of Escitalopram for the Treatment of Depression in Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups
研究概览
简要总结
Purpose : to Evaluation of the Efficacy of Escitalopram for the Treatment of Depression in Alzheimer's Disease
Trial Design : A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial with an open-label, 12-week extension
详细描述
Clinical trial agreement signed by the parties to the subjects through a process of screening. if it is consider suitable for evaluating through the selection / exclusion criteria, they will be randomly assigned to the test group or control group (placebo).
Assigned to the test group or control subjects, they will be prescribe the 5mg Escitalopram or Placebo. without regard to meals, it will be taking once a day.
and than It should be increased the capacity every two weeks by 5mg/day up to a maximum 15mg/day.
and than, on the treatment for a 8 weeks, If you don't find the side effect, Maintaining the same capacity. If you find the side effect, you should lose capacity.(10mg/day)
The test group or control subjects, will receive a doctor's examination and inspection through six visits for a 24weeks from the date of the randomly assigned participants.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over the age of 50
- •Medical diagnostic criteria must meet the standard.
- •Subject diagnosed with Alzheimer's disease in accordance with NINCDS-ADRDA Criteria.
- •Subject with three or more symptoms of the Olin depression (major depressive episode) diagnostic criteria.
- •clinical dementia rating (CDR) of 0.5 to 2
- •MMSE 10 ~ 26 (K-MMSE)
- •GDS-15 ≥ 5 points
- •When screening, Cholinesterase inhibitors taking a minimum of four weeks or more stable subject.
- •During the clinical trials, Subject does not change the capacity of Cholinesterase Inhibitors.
- •MRI or CT results within 24 months of subject with Alzheimer's disease (AD)
- •Participation in clinical trials to determine their own and written informed consent form and subject who actively perform clinical procedure including the questionnaire. But the subjects with cognitive dysfunction that cannot voluntarily make the decision, can be determined by an authorized representative to participate in.
- •Subjects must be accompanied their guardian to every visit. More than three days a week, more than 4 hours per day, spend the day with the guardian.
排除标准
- •If you are taking other depression drugs within 4 weeks before the start of the clinical trials(e.g. SSRI, Stablon, TCA, wellbutrin, ixel)
- •If you have any other mental illness (bipolar disorder, schizophrenia, etc.)
- •If you have a serious medical illness (heart failure, angina pectoris, myocardial infarction, arteriosclerosis, etc.) or psychiatric illness.
- •Seizures, brain surgery, organic brain disease and history of organic affective disorder and at the brain MRI, abnormalities other than brain atrophy.
- •If you have a history of the test drug hypersensitivity
- •If you are taking memantin (dementia)
- •If you participated in another clinical trial within 3 months.
- •If pregnant or fertile women, who have not received sterilization or if you do not want to use an effective method of contraception.
- •In laboratory tests, if you have kidney failure or liver failure.
- •If you have history or habitual drinking or a history of drug abuse.
- •Uncontrolled diabetes or hypertension.
- •If determined to be inappropriate for clinical trials.
研究组 & 干预措施
Placebo
placebo 15mg
干预措施: Placebo (Drug)
escitalopram
escitalopram 15mg
干预措施: escitalopram (Drug)
结局指标
主要结局
Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups
时间窗: 12 weeks
Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups.
次要结局
- Change from baseline in CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.(24weeks)
- Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24.(24 weeks)
- Change from baseline in CDR at week 12 and 24.(24 weeks)
- Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24.(24 weeks)
- Change from baseline in K-MMSE at week 12 and 24.(24 weeks)
- Change from baseline in ADAS-Cog at week 12 and 24.(24 weeks)
- Change from baseline in NPIQ at week 12 and 24.(24 weeks)
- Change from baseline in S-IADL at week 12 and 24.(24 weeks)
- Change from baseline in CDR sum of box at week 12 and 24.(24 weeks)
研究者
Seol-Heui Han
Clinical Professor
Konkuk University Medical Center