An Observational Study for the Prevalence of Neuropsychiatric Symptom in Parkinson's Disease Dementia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Six-month Observational Study to Investigate Prevalence of Neuropsychiatric Symptom in Korean Patients With Parkinson's Disease Dementia

Conditions
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Parkinson's Disease Dementia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric inventory | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up neuropsychiatric inventory | The change of prevalence of neuropsychiatric symptoms after choline esterase inhibitor treatment. | Six months after choline esterase inhibitor treatment | 
| Care-giver burden_baseline | The burden of caregiver determined by Burden Interview(BI) and Caregiver Burden inventory(CBI) | Baseline | 
| Care-giver burden change | The burden change of caregiver using the same scale (BI and CBI). | Six months after choline esterase inhibitor treatment | 
| Motor function_baseline | Hoehn and Yahr stage and Unified Parkinson's disease rating scale, part 3 | Baseline | 
| Motor function_change | Hoehn and Yahr stage and Unified Parkinson's Disease Rating Scale | Six months after choline esterase inhibitor treatment | 
| General cognitive function_baseline | The Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL | Baseline | 
| General cognitive function_change | The Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL | Six months after choline esterase inhibitor treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease dementia, neuropsychiatric symptoms