Dementia Registry for Parkinson's Disease
| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 30, 2010 |
| Last Updated Date | February 13, 2012 |
| Start Date ICMJE | November 2010 |
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01251094 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Dementia Registry for Parkinson's Disease |
| Official Title ICMJE | Not Provided |
| Brief Summary | Background Cognitive impairment in Parkinson's disease (PD) is common, even in the early stage of this disease.The cumulative prevalence of dementia associated with Parkinson's disease (PDD) is as high as 80% in a recent 8-year prospective study. However, some kinds of cognitive impairment are not apparent and the value of self-report cognitive decline became limited. In other words, some cognitive impairment may be detected by cognitive tests rather than self-report of the symptoms.The early intervention of the cognitive impairment may be helpful for these patients. Neuropsychiatric symptoms(NPSs) are also common in PD and PDD patients. The severity of NPSs contributes to reduced quality of life and distress for caregivers. Previous studies showed some different clinical phenotypes of NPSs in PD or PDD patients. Among the NPSs, hallucination was considered a critical factor of cognitive dysfunction in PD and PDD patients. The co-occurrence of NPSs in PD and PDD patients has limited evidence now. Purpose To establish the screening tools for early detecting the PD patient with cognitive impairment; exam the diagnostic value of MoCA and other cognitive tests in PD with mild cognitive impairment, possible PDD, and probable PDD; understand neuropsychiatric symptoms (NPSs) in these different patient groups; exam the relationship between each NPS and each domain of cognitive dysfunction. Methods In order to exam the cognitive dysfunction in PDD (attention, executive function, visuo-spatial function, and memory), several tests are performed. A 32-item cognitive decline questionnaire will be used to screen the cognitive impairment in subjects. Mini-Mental state examination (MMSE) and Montreal cognitive assessment (MoCA)are used for cognitive evaluation. The detail evaluation of each domain is specified asfollowing: (1) Attention (WAIS-R digit span), (2) Memory (12-item word recall test),(3) Executive function (category verbal fluency), (4) Visuospatial function (cube copying and clock drawing). The motor symptoms severity of the PD will be evaluated by the Hoehn & Yahr stage and motor portion of the Unified Parkinson's Disease Rating Scale (UPDRS). The neuropsychiatric symptoms will be recorded by Neuropsychiatric Inventory Questionnaire (NPI-Q). The daily living activity will beevaluated by modified Lawton's instrumental activities of daily living scale (IADL)and pill questionnaire. Subjects also receive 15-item Geriatric Depression Scale(GDS-S) to evaluate the mood status. The clinician's diagnosis of dementia will be based on the diagnostic criteria of DSM-IV, which will be compared with the PDDdiagnostic criteria proposed by MDS in 2007. The investigators will also try to develop a PDDscreening questionnaire. Expected results Cognitive impairment and dementia of PD patients will be ascertained by the cognitive test battery. The screening questionnaire will be established. The heterogeneity of NPSs in PD and PDD will be evaluated. The PDD screening questionnaire will help the clinician to diagnose the patients. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | Parkinson's Disease patients. |
| Condition ICMJE |
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| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 30 |
| Completion Date | November 2011 |
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Presence of any of the following criteria will exclude the subject from enrollment in the study:
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| Gender | Both |
| Ages | 50 Years to 90 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Taiwan |
| Administrative Information | |
| NCT Number ICMJE | NCT01251094 |
| Other Study ID Numbers ICMJE | DRM99-IRB-233 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | China Medical University Hospital |
| Study Sponsor ICMJE | China Medical University Hospital |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | China Medical University Hospital |
| Verification Date | February 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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