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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01102582
Other study ID # Norva100408
Secondary ID
Status Completed
Phase N/A
First received April 8, 2010
Last updated February 2, 2015
Start date April 2010
Est. completion date February 2011

Study information

Verified date February 2015
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of The Catholic University of Korea, Yonsei University Seoul

Sponsors (2)

Lead Sponsor Collaborator
The Catholic University of Korea Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Aarsland D, Brønnick 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. Epub 2006 Jul 4. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Follow-up neuropsychiatric inventory The change of prevalence of neuropsychiatric symptoms after choline esterase inhibitor treatment. Six months after choline esterase inhibitor treatment No
Secondary Care-giver burden_baseline The burden of caregiver determined by Burden Interview(BI) and Caregiver Burden inventory(CBI) Baseline No
Secondary Care-giver burden change The burden change of caregiver using the same scale (BI and CBI). Six months after choline esterase inhibitor treatment No
Secondary Motor function_baseline Hoehn and Yahr stage and Unified Parkinson's disease rating scale, part 3 Baseline No
Secondary Motor function_change Hoehn and Yahr stage and Unified Parkinson's Disease Rating Scale Six months after choline esterase inhibitor treatment No
Secondary General cognitive function_baseline The Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL Baseline No
Secondary 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 No
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