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
Recruitment status was Recruiting
Sponsor:
The Catholic University of Korea
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) |
- 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
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 May 16, 2013