Ignite Creation Date:
2024-05-05 @ 11:51 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01436552
Status:
UNKNOWN
Last Update Posted:
2011-09-19
First Post:
2011-09-16
Brief Title:
Psychopathological Risk Factors Associated With Conversion From Mild Cognitive Impairment to Dementia
Sponsor:
Centre Hospitalier Esquirol
Organization:
Centre Hospitalier Esquirol
Study Overview
Official Title:
Psychopathological Risk Factors Associated With Conversion From Mild Cognitive Impairment to Dementia
Status:
UNKNOWN
Status Verified Date:
2010-02
Last Known Status:
RECRUITING
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:
FPRMCI
Brief Summary:
Background Dementias Alzheimers disease and related syndromes in their sporadic form have multifactorial origin Several risk factors RF are currently recognized like the cardiovascular RF some genes of susceptibility but the impact 1 of traumatic life events TLE considered as psychosocial RF Persson Skoog 1996 Charles et al 2006 2 of anxiety andor depression 3 of the premorbid personality Clément et al 2003 with his coping strategies and 4 of the lifestyle which results from the personality for the moment are still underestimated Dementia disease can be clinically preceded by a mild cognitive impairment MCI Petersen et al 1996 which is however potentially reversible
Purpose Actually there is no study concerning the rate of conversion from MCI to dementia according to the presence or not of TLE The aim of this study is to assess association between TLE and conversion rate from MCI to dementia
Methods Patients with MCI will be recruited in different memory clinics Limoges and others Primary outcome Occurrence of dementia according to DSM-IV-TR criteria in MCI patients according to their cumulated score of TLE measured by EVVIE
Secondary outcomes Occurrence of dementia in MCI patients according to various other psychopathological factors anxiety depression apathy personality features alexithymia and resilience levels and life style
Study design Epidemiologic cohort longitudinal and prospective multicenter study
Purpose Actually there is no study concerning the rate of conversion from MCI to dementia according to the presence or not of TLE The aim of this study is to assess association between TLE and conversion rate from MCI to dementia
Methods Patients with MCI will be recruited in different memory clinics Limoges and others Primary outcome Occurrence of dementia according to DSM-IV-TR criteria in MCI patients according to their cumulated score of TLE measured by EVVIE
Secondary outcomes Occurrence of dementia in MCI patients according to various other psychopathological factors anxiety depression apathy personality features alexithymia and resilience levels and life style
Study design Epidemiologic cohort longitudinal and prospective multicenter study
Detailed Description:
Eligibility criteria
Inclusion criteria
Man or woman 50 years
Patient with MCI of any type according to the criteria of Petersen et al 2001
Clinical Dementia Rating CDR 05
Instrumental activities of daily living IADL0
MMSE 26
Cognitive and functional capacities well enough in order to avoid a possible diagnosis of Alzheimers disease based on clinical evidences DSM-IV TR cannot be done during initial visit
Ambulatory patient
Visual and auditory capabilities equipment allowed and oral or written capacity able for the development of suitable tests according to the clinician
exclusion criteria
Patient with identified neurological problems
Patient with developing and or non-stabilized psychiatric disease
Patient with biological disorders observed during diagnostic process Number of subjects 392 subjects Statistical analysis Statistical analyses will be performed by the Unité Fonctionnelle de Recherche Clinique et de Biostatistique from the Limoges teaching hospital using SAS V 913 software SAS Institute Cary NC Level of significance will be 005 for all analyses Statistical analyses will be performed and presented in agreement with STROBE guidelines
Descriptive analyses
Quantitative variables will be described using mean standard deviation or median and interquartile range Qualitative variables will be described using frequencies percentages and 95 confidence intervals assessed with exact method
A flow chart of patients will be presented
Main analysis Association between dementia and EVVIE score will be assessed through relative risk calculation 95 confidence interval will also be calculated
Inclusion criteria
Man or woman 50 years
Patient with MCI of any type according to the criteria of Petersen et al 2001
Clinical Dementia Rating CDR 05
Instrumental activities of daily living IADL0
MMSE 26
Cognitive and functional capacities well enough in order to avoid a possible diagnosis of Alzheimers disease based on clinical evidences DSM-IV TR cannot be done during initial visit
Ambulatory patient
Visual and auditory capabilities equipment allowed and oral or written capacity able for the development of suitable tests according to the clinician
exclusion criteria
Patient with identified neurological problems
Patient with developing and or non-stabilized psychiatric disease
Patient with biological disorders observed during diagnostic process Number of subjects 392 subjects Statistical analysis Statistical analyses will be performed by the Unité Fonctionnelle de Recherche Clinique et de Biostatistique from the Limoges teaching hospital using SAS V 913 software SAS Institute Cary NC Level of significance will be 005 for all analyses Statistical analyses will be performed and presented in agreement with STROBE guidelines
Descriptive analyses
Quantitative variables will be described using mean standard deviation or median and interquartile range Qualitative variables will be described using frequencies percentages and 95 confidence intervals assessed with exact method
A flow chart of patients will be presented
Main analysis Association between dementia and EVVIE score will be assessed through relative risk calculation 95 confidence interval will also be calculated
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