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

NCT01102582 | Completed DMC

• 1 other identifier: Norva100408
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease Dementia

Keywords

Parkinson's disease dementia, neuropsychiatric symptoms

Outcome Measures

Primary Outcomes (1)

• Neuropsychiatric inventory

  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 Outcomes (7)

• Follow-up neuropsychiatric inventory

  Six months after choline esterase inhibitor treatment

• Care-giver burden_baseline

  Baseline

• Care-giver burden change

  Six months after choline esterase inhibitor treatment

• Motor function_baseline

  Baseline

• Motor function_change

  Six months after choline esterase inhibitor treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The tertiary clinic in university hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Yonsei University: collaborator

Study Sites (1)

The Catholic University of Korea, Yonsei University

Seoul, Seoul, 137-701, South Korea

Location

Related Publications (2)

• 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.

  PMID: 11241724 BACKGROUND

• 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.

  PMID: 16820421 BACKGROUND

Study Officials

• Joong-Seok Kim, MD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 13, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

KR (1)