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

NCT ID: NCT01102582

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-02-28

Brief 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.

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.

Conditions

Parkinson's Disease Dementia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: collaborator

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Joong-Seok Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joong-Seok Kim, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

The Catholic University of Korea, Yonsei University

Seoul, Seoul, South Korea

Countries

South Korea

References

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. doi: 10.1002/1099-1166(200102)16:23.0.co;2-k.

Reference Type: BACKGROUND

PMID: 11241724 (View on PubMed)

Aarsland D, Bronnick 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. doi: 10.1136/jnnp.2005.083113. Epub 2006 Jul 4.

Reference Type: BACKGROUND

PMID: 16820421 (View on PubMed)

Other Identifiers

Norva100408

Identifier Type: -

Identifier Source: org_study_id