Clinical trial NCT01102582: An Observational Study for the Prevalence of Neuropsychiatric Symptom in Parkinson's Disease Dementia
Official title: A Six-month Observational Study to Investigate Prevalence of Neuropsychiatric Symptom in Korean Patients With Parkinson's Disease Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease Dementia
Keywords: Parkinson's disease dementia, neuropsychiatric symptoms
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Yonsei University
First posted: 2010-04-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The tertiary clinic in university hospital

Brief summary: * 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: * 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neuropsychiatric inventory
timeFrame: Baseline
Secondary outcomes:
measure: Follow-up neuropsychiatric inventory
timeFrame: Six months after choline esterase inhibitor treatment
measure: Care-giver burden_baseline
timeFrame: Baseline
measure: Care-giver burden change
timeFrame: Six months after choline esterase inhibitor treatment
measure: Motor function_baseline
timeFrame: Baseline
measure: Motor function_change
timeFrame: Six months after choline esterase inhibitor treatment
measure: General cognitive function_baseline
timeFrame: Baseline
measure: General cognitive function_change
timeFrame: Six months after choline esterase inhibitor treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yonsei University
Study officials:
affiliation: The Catholic University of Korea
name: Joong-Seok Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aarsland D, Cummings JL, Larsen JP. Neuropsychiatric differences between Parkinson's disease with dementia and Alzheimer's disease. Int J Geriatr Psychiatry. 2001 Feb;16(2):184-91. doi: 10.1002/1099-1166(200102)16:23.0.co;2-k.
citation: Aarsland D, Bronnick K, Ehrt U, De Deyn PP, Tekin S, Emre M, Cummings JL. Neuropsychiatric symptoms in patients with Parkinson's disease and dementia: frequency, profile and associated care giver stress. J Neurol Neurosurg Psychiatry. 2007 Jan;78(1):36-42. doi: 10.1136/jnnp.2005.083113. Epub 2006 Jul 4.