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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by The Catholic University of Korea.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Yonsei University
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01102582
First received: April 8, 2010
Last updated: April 15, 2010
Last verified: April 2010
  Purpose
  • 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.

Condition
Parkinson's Disease Dementia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Six-month Observational Study to Investigate Prevalence of Neuropsychiatric Symptom in Korean Patients With Parkinson's Disease Dementia

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Neuropsychiatric inventory [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Follow-up neuropsychiatric inventory [ Time Frame: Six months after choline esterase inhibitor treatment ] [ Designated as safety issue: No ]
    The change of prevalence of neuropsychiatric symptoms after choline esterase inhibitor treatment.

  • Care-giver burden_baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The burden of caregiver determined by Burden Interview(BI) and Caregiver Burden inventory(CBI)

  • Care-giver burden change [ Time Frame: Six months after choline esterase inhibitor treatment ] [ Designated as safety issue: No ]
    The burden change of caregiver using the same scale (BI and CBI).

  • Motor function_baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Hoehn and Yahr stage and Unified Parkinson's disease rating scale, part 3

  • Motor function_change [ Time Frame: Six months after choline esterase inhibitor treatment ] [ Designated as safety issue: No ]
    Hoehn and Yahr stage and Unified Parkinson's Disease Rating Scale

  • General cognitive function_baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL

  • General cognitive function_change [ Time Frame: Six months after choline esterase inhibitor treatment ] [ Designated as safety issue: No ]
    The Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL


Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The tertiary clinic in university hospital

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102582

Contacts
Contact: Joong-Seok Kim, MD +822 2258 6078 neuronet@catholic.ackr
Contact: Phil Hyu Lee, MD +822 2228 5230 phisland@chol.com

Locations
Korea, Republic of
The Catholic University of Korea, Yonsei University Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Joong-Seok Kim, MD    +822 2258 6078    neuronet@catholic.ac.kr   
Contact: Phil Hyu Lee, MD    +822 2228 5230    phisland@chol.com   
Sponsors and Collaborators
The Catholic University of Korea
Yonsei University
Investigators
Principal Investigator: Joong-Seok Kim, MD The Catholic University of Korea
  More Information

Publications:
Responsible Party: Joong-Seok Kim/ Associate Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01102582     History of Changes
Other Study ID Numbers: Norva100408
Study First Received: April 8, 2010
Last Updated: April 15, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
Parkinson's disease dementia, neuropsychiatric symptoms

Additional relevant MeSH terms:
Dementia
Parkinson Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 18, 2014