Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01102582
Enrollment
48
Registered
2010-04-13
Start date
2010-04-30
Completion date
2011-02-28
Last updated
2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease Dementia

Keywords

Parkinson's disease dementia, neuropsychiatric symptoms

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.

Interventions

None listed

Sponsors

Yonsei University
CollaboratorOTHER
The Catholic University of Korea
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Neuropsychiatric inventoryBaselineIt 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.

Secondary

MeasureTime frameDescription
Care-giver burden_baselineBaselineThe burden of caregiver determined by Burden Interview(BI) and Caregiver Burden inventory(CBI)
Care-giver burden changeSix months after choline esterase inhibitor treatmentThe burden change of caregiver using the same scale (BI and CBI).
Motor function_baselineBaselineHoehn and Yahr stage and Unified Parkinson's disease rating scale, part 3
Follow-up neuropsychiatric inventorySix months after choline esterase inhibitor treatmentThe change of prevalence of neuropsychiatric symptoms after choline esterase inhibitor treatment.
General cognitive function_baselineBaselineThe Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL
General cognitive function_changeSix months after choline esterase inhibitor treatmentThe Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL
Motor function_changeSix months after choline esterase inhibitor treatmentHoehn and Yahr stage and Unified Parkinson's Disease Rating Scale

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026