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

February 2, 2015 updated by: Joong-Seok Kim, The Catholic University of Korea

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

  • 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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea, Yonsei University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The tertiary clinic in university hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric inventory
Time Frame: Baseline
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up neuropsychiatric inventory
Time Frame: Six months after choline esterase inhibitor treatment
The change of prevalence of neuropsychiatric symptoms after choline esterase inhibitor treatment.
Six months after choline esterase inhibitor treatment
Care-giver burden_baseline
Time Frame: Baseline
The burden of caregiver determined by Burden Interview(BI) and Caregiver Burden inventory(CBI)
Baseline
Care-giver burden change
Time Frame: Six months after choline esterase inhibitor treatment
The burden change of caregiver using the same scale (BI and CBI).
Six months after choline esterase inhibitor treatment
Motor function_baseline
Time Frame: Baseline
Hoehn and Yahr stage and Unified Parkinson's disease rating scale, part 3
Baseline
Motor function_change
Time Frame: Six months after choline esterase inhibitor treatment
Hoehn and Yahr stage and Unified Parkinson's Disease Rating Scale
Six months after choline esterase inhibitor treatment
General cognitive function_baseline
Time Frame: Baseline
The Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL
Baseline
General cognitive function_change
Time Frame: Six months after choline esterase inhibitor treatment
The Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL
Six months after choline esterase inhibitor treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Collaborators

Yonsei University

Investigators

  • Principal Investigator: Joong-Seok Kim, MD, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Norva100408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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