Psychopathological Risk Factors Associated With Conversion From Mild Cognitive Impairment to Dementia (FPRMCI)
|ClinicalTrials.gov Identifier: NCT01436552|
Recruitment Status : Unknown
Verified February 2010 by Jean Pierre Clement, Centre Hospitalier Esquirol.
Recruitment status was: Recruiting
First Posted : September 19, 2011
Last Update Posted : September 19, 2011
Background: Dementias (Alzheimer's 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  of traumatic life events (TLE), considered as psychosocial RF (Persson & Skoog, 1996; Charles et al, 2006),  of anxiety and/or depression,  of the premorbid personality (Clément et al, 2003) with his coping strategies, and  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.
|Condition or disease|
|Mild Cognitive Impairment|
- Man or woman ≥ 50 years.
- Patient with MCI, of any type, according to the criteria of Petersen et al, 2001.
- Clinical Dementia Rating (CDR) ≤ 0,5.
- Instrumental activities of daily living (IADL)=0.
- MMSE > 26.
- Cognitive and functional capacities well enough in order to avoid a possible diagnosis of Alzheimer's 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).
- 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 9.1.3 software (SAS Institute Cary, NC). Level of significance will be 0.05 for all analyses. Statistical analyses will be performed and presented in agreement with STROBE guidelines.
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 Type :||Observational|
|Estimated Enrollment :||392 participants|
|Official Title:||Psychopathological Risk Factors Associated With Conversion From Mild Cognitive Impairment to Dementia|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||February 2012|
|Estimated Study Completion Date :||February 2014|
- Occurrence of dementia according to DSM-IV-TR criteria in MCI patients according to their cumulated score of TLE measured by EVVIE. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436552
|Limoges, France, 87025|
|Contact: Annie Druet-Cabanac, PhD +33555431215 firstname.lastname@example.org|
|Sub-Investigator: Benjamin Calvet, MD|
|Sub-Investigator: Leslie Cartz-Piver, MD|
|Sub-Investigator: Laurence Bernard-Bourzeix, MD|
|Principal Investigator:||Jean-Pierre Clement, MD, PhD||CH Esquirol|