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

Parkinson's Disease Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102582
• Other study ID #: Norva100408
• 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

• Dementia
• Parkinson Disease
• Parkinson's Disease Dementia

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