Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01251094
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2010-11-30
Brief Title:
Dementia Registry for Parkinsons Disease
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Cognitive impairment in Parkinsons disease PD is common even in the early stage of this diseaseThe cumulative prevalence of dementia associated with Parkinsons 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 symptomsThe early intervention of the cognitive impairment may be helpful for these patients Neuropsychiatric symptomsNPSs 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 MoCAare 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 test3 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 Parkinsons Disease Rating Scale UPDRS The neuropsychiatric symptoms will be recorded by Neuropsychiatric Inventory Questionnaire NPI-Q The daily living activity will beevaluated by modified Lawtons instrumental activities of daily living scale IADLand pill questionnaire Subjects also receive 15-item Geriatric Depression ScaleGDS-S to evaluate the mood status The clinicians 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
Cognitive impairment in Parkinsons disease PD is common even in the early stage of this diseaseThe cumulative prevalence of dementia associated with Parkinsons 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 symptomsThe early intervention of the cognitive impairment may be helpful for these patients Neuropsychiatric symptomsNPSs 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 MoCAare 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 test3 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 Parkinsons Disease Rating Scale UPDRS The neuropsychiatric symptoms will be recorded by Neuropsychiatric Inventory Questionnaire NPI-Q The daily living activity will beevaluated by modified Lawtons instrumental activities of daily living scale IADLand pill questionnaire Subjects also receive 15-item Geriatric Depression ScaleGDS-S to evaluate the mood status The clinicians 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None