NCT01102582已完成不适用
A Six-month Observational Study to Investigate Prevalence of Neuropsychiatric Symptom in Korean Patients With Parkinson's Disease Dementia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Neuropsychiatric inventory
研究概览
简要总结
- Dementia correlates to decreased cognitive function, and Behavioral and Psychological Symptoms of Dementia (Neuropsychiatric symptom, BPSD) as well.
- Neuropsychiatric symptom attributes important role for mortality, mortality, and cause to enter nursing home.
- Study on neuropsychiatric symptom in patients with Parkinson's disease has not been thorough yet, and there even has not been any study done on this in Korea yet.
- The investigators will study prevalence of neuropsychiatric symptom in PDD patients and burden of caregiver.
详细描述
- It is well recognized that the importance of non-motor symptoms of Parkinson's disease during its progression and many patients are suffering from this. The deterioration of cognitive function is especially known as a crucial prognostic factor. According to recently released cohort study, majority of patients go through dementia in advanced Parkinson's disease.
- Dementia correlates to decreased cognitive function, and Behavioral and Psychological Symptoms of Dementia (Neuropsychiatric symptom, BPSD) as well. Neuropsychiatric symptom composed of abnormal behavior and psychological symptoms: abnormal behaviors include combativeness, wandering, agitation, akathisia, inappropriate sexual behavior, following caregiver, shouting, cursing, insomnia and binge eating while psychological symptoms include anxiety, depression, hallucination, and illusion. Neuropsychiatric symptom is evaluated depending on information given by caregivers, and symptoms are likely to be temporary or changing constantly. Two thirds of patients is found to have neuropsychiatric symptom when they are diagnosed as dementia, 65 % in nursing home and 70~90% in advanced dementia states. Neuropsychiatric symptom attributes important role for mortality, mortality, and cause to enter nursing home.
- Besides, neuropsychiatric symptom also plays important part as care-giver burden. It gives heavier burden on caregiver rather than on patients, and increases depression and anxiety of caregivers. Specific correlation with patient's neuropsychiatric symptom to burden of caregiver is known as agitation, depression, aggression, repetitive behavior, anxiety, and disinhibition. There are, however, various results related to race, region, subjects, and investigator.
- Study on neuropsychiatric symptom in patients with Parkinson's disease dementia has not been thorough yet, and there even has not been any study done on this in Korea yet.
- The investigators will study prevalence of neuropsychiatric symptom in PDD patients and burden of caregiver.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were diagnosed of Parkinson's disease dementia.
- •Written informed consent will be obtained from the patient (if possible) or from the patient's legal guardian or other representative prior to beginning the any baseline assessments or activities. Even if unable to provide written informed consent, the patient must assent verbally to participating in the study.
- •The regimen for levodopa that was administered regularly to patients for 1 month before the enrollment can be adjusted optimally for the patients during the investigation.
- •Patients with other dopamine enhancer, MAO-B inhibitor or Amantadine administered should be kept stable state during this study.
- •Patients who have been on other medication for 1 month before they are enrolled can be included if the investigator decides that those medication won't affect the result of the study.
- •Other medication for the treatment of other disease can be administered under discussion with the physician in charge or those medications.
排除标准
- •Patients who are under other study.
- •Patients with other systemic disease who are to be limited for drug administration.
- •Patients who are pregnant.
- •Participants are not allowed to take any other medication that can affect cognitive function e.g, anti-cholinergic medications, benztropine, trihexphenidyl, and biperidene.
结局指标
主要结局
Neuropsychiatric inventory
时间窗: Baseline
It collects information on symptoms during the past month in 10 domains-delusions, hallucinations, agitation, depression, anxiety, elation, apathy, disinhibition, irritability, and aberrant motor behaviors-using a structured interview with a knowledgeable informant.
次要结局
- Care-giver burden change(Six months after choline esterase inhibitor treatment)
- Motor function_change(Six months after choline esterase inhibitor treatment)
- Follow-up neuropsychiatric inventory(Six months after choline esterase inhibitor treatment)
- Care-giver burden_baseline(Baseline)
- Motor function_baseline(Baseline)
- General cognitive function_baseline(Baseline)
- General cognitive function_change(Six months after choline esterase inhibitor treatment)
研究者
Joong-Seok Kim
Professor
The Catholic University of Korea
研究点 (1)
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