Mild Cognitive ImpairmentFPRMCINCT01436552
Psychopathological Risk Factors Associated With Conversion From Mild Cognitive Impairment to Dementia
An observational study of Mild Cognitive Impairment, run by Centre Hospitalier Esquirol at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 392 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with MCI will be recruited in different memory clinics (Limoges and others)
Who may be able to join
- 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).
Who cannot join
- Patient with identified neurological problems.
- Patient with developing and/ or non-stabilized psychiatric disease.
- Patient with biological disorders observed during diagnostic process.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CH Esquirol
Limoges, 87025
Annie Druet-Cabanac, PhD, +33555431215, aniejean@hotmail.com
Benjamin Calvet, MD
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Keywords
- MCI, Depression, Alzheimer, Life events
- Medical subject headings
- Cognitive Dysfunction, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dementia according to DSM-IV-TR criteria in MCI patients according to their cumulated score of TLE measured by EVVIE.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Pierre Clement, Centre Hospitalier Esquirol
- Investigators
- Jean-Pierre Clement, MD, PhD, Principal investigator, CH Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436552
- Sponsor's protocol ID
- B1001104-10
- Acronym
- FPRMCI
- Status last verified
- Feb 2010
- First submitted
- 16 Sep 2011
- Last updated
- 19 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychopathological Risk Factors Associated With Conversion From Mild Cognitive Impairment to Dementia
- ClinicalTrials.gov ID
- NCT01436552
- Acronym / sponsor ID
- FPRMCI / B1001104-10
- Conditions
- Mild Cognitive Impairment
- Keywords
- MCI, Depression, Alzheimer, Life events
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MCI will be recruited in different memory clinics (Limoges and others)
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient with identified neurological problems.
- Patient with developing and/ or non-stabilized psychiatric disease.
- Patient with biological disorders observed during diagnostic process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre Clement, MD, PhD principal investigator
CH Esquirol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Centre Hospitalier Esquirol at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2011; AzTrials last refreshed its copy on 3 Nov 2026.