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Psychopathological Risk Factors Associated With Conversion From Mild Cognitive Impairment to Dementia (FPRMCI)

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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
Sponsor:
Information provided by (Responsible Party):
Jean Pierre Clement, Centre Hospitalier Esquirol

Brief Summary:

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 [1] of traumatic life events (TLE), considered as psychosocial RF (Persson & Skoog, 1996; Charles et al, 2006), [2] of anxiety and/or 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.


Condition or disease
Mild Cognitive Impairment

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) ≤ 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).
  • 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 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.

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 Type : Observational
Estimated Enrollment : 392 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with MCI will be recruited in different memory clinics (Limoges and others)
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) ≤ 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).

Exclusion Criteria:

  • Patient with identified neurological problems.
  • Patient with developing and/ or non-stabilized psychiatric disease.
  • Patient with biological disorders observed during diagnostic process.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436552


Locations
France
CH Esquirol Recruiting
Limoges, France, 87025
Contact: Annie Druet-Cabanac, PhD    +33555431215    aniejean@hotmail.com   
Sub-Investigator: Benjamin Calvet, MD         
Sub-Investigator: Leslie Cartz-Piver, MD         
Sub-Investigator: Laurence Bernard-Bourzeix, MD         
Sponsors and Collaborators
Centre Hospitalier Esquirol
Investigators
Principal Investigator: Jean-Pierre Clement, MD, PhD CH Esquirol

Responsible Party: Jean Pierre Clement, Professor of Psychiatry -Ph.D, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier: NCT01436552     History of Changes
Other Study ID Numbers: B1001104-10
First Posted: September 19, 2011    Key Record Dates
Last Update Posted: September 19, 2011
Last Verified: February 2010

Keywords provided by Jean Pierre Clement, Centre Hospitalier Esquirol:
MCI
Depression
Alzheimer
Life events

Additional relevant MeSH terms:
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders