Parkinson's Disease DementiaNCT01102582
An Observational Study for the Prevalence of Neuropsychiatric Symptom in Parkinson's Disease Dementia
An observational study of Parkinson's Disease Dementia, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease Dementia
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The tertiary clinic in university hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Yonsei University
Seoul, Seoul, 137-701
About this study
Official title: 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.
Read the 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
- Keywords
- Parkinson's disease dementia, neuropsychiatric symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (7)
Follow-up neuropsychiatric inventory
The change of prevalence of neuropsychiatric symptoms after choline esterase inhibitor treatment.
Measured: Six months after choline esterase inhibitor treatment
Care-giver burden_baseline
The burden of caregiver determined by Burden Interview(BI) and Caregiver Burden inventory(CBI)
Measured: Baseline
Care-giver burden change
The burden change of caregiver using the same scale (BI and CBI).
Measured: Six months after choline esterase inhibitor treatment
Motor function_baseline
Hoehn and Yahr stage and Unified Parkinson's disease rating scale, part 3
Measured: Baseline
Motor function_change
Hoehn and Yahr stage and Unified Parkinson's Disease Rating Scale
Measured: Six months after choline esterase inhibitor treatment
General cognitive function_baseline
The Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL
Measured: Baseline
General cognitive function_change
The Korean version of mini mental status examination, clinical dementia rating, Barthel and Instrumental ADL
Measured: Six months after choline esterase inhibitor treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Yonsei University
- Responsible party
- Principal investigator, Joong-Seok Kim, The Catholic University of Korea
- Investigators
- Joong-Seok Kim, MD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102582
- Sponsor's protocol ID
- Norva100408
- Status last verified
- Feb 2015
- First submitted
- 8 Apr 2010
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11241724Aarsland 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.
PubMed 16820421
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-month Observational Study to Investigate Prevalence of Neuropsychiatric Symptom in Korean Patients With Parkinson's Disease Dementia
- ClinicalTrials.gov ID
- NCT01102582
- Acronym / sponsor ID
- Norva100408
- Conditions
- Parkinson's Disease Dementia
- Keywords
- Parkinson's disease dementia, neuropsychiatric symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Yonsei University
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The tertiary clinic in university hospital
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Follow-up neuropsychiatric inventory
Time frame: Six months after choline esterase inhibitor treatment
Care-giver burden_baseline
Time frame: Baseline
Care-giver burden change
Time frame: Six months after choline esterase inhibitor treatment
Motor function_baseline
Time frame: Baseline
Motor function_change
Time frame: Six months after choline esterase inhibitor treatment
General cognitive function_baseline
Time frame: Baseline
General cognitive function_change
Time frame: Six months after choline esterase inhibitor treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Background: PubMed 11241724Aarsland 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.
- Background: PubMed 16820421Aarsland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joong-Seok Kim, MD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease Dementia, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric inventory (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01102582, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.