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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Centre Hospitalier Esquirol.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jean Pierre Clement, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier:
NCT01436552
First received: September 16, 2011
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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
Mild Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychopathological Risk Factors Associated With Conversion From Mild Cognitive Impairment to Dementia

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Esquirol:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 392
Study Start Date: February 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: September 16, 2011
Last Updated: September 16, 2011
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Esquirol:
MCI
Depression
Alzheimer
Life events

Additional relevant MeSH terms:
Dementia
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014