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NCT Number: NCT01102582

An Observational Study for the Prevalence of Neuropsychiatric Symptom in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Catholic University of Korea, Yonsei University

Seoul, 137-701, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Care-giver burden_baseline

    Time frame: Baseline

    The burden of caregiver determined by Burden Interview(BI) and Caregiver Burden inventory(CBI)

  3. 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).

  4. Motor function_baseline

    Time frame: Baseline

    Hoehn and Yahr stage and Unified Parkinson's disease rating scale, part 3

  5. Motor function_change

    Time frame: Six months after choline esterase inhibitor treatment

    Hoehn and Yahr stage and Unified Parkinson's Disease Rating Scale

  6. General cognitive function_baseline

    Time frame: Baseline

    The Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL

  7. 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

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Collaborators

  • Yonsei University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 13, 2010
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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