Psychopathological Risk Factors Associated With Conversion From Mild Cognitive Impairment to Dementia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Occurrence of dementia according to DSM-IV-TR criteria in MCI patients according to their cumulated score of TLE measured by EVVIE.
研究概览
简要总结
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.
详细描述
Eligibility criteria:
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Inclusion criteria:
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Man or woman ≥ 50 years.
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Patient with MCI, of any type, according to the criteria of Petersen et al, 2001.
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Clinical Dementia Rating (CDR) ≤ 0,5.
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Instrumental activities of daily living (IADL)=0.
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MMSE > 26.
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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.
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Ambulatory patient.
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Visual and auditory capabilities (equipment allowed) and oral or written capacity able for the development of suitable tests (according to the clinician).
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exclusion criteria:
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Patient with identified neurological problems.
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Patient with developing and/ or non-stabilized psychiatric disease.
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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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman ≥ 50 years.
- •Patient with MCI, of any type, according to the criteria of Petersen et al,
- •Clinical Dementia Rating (CDR) ≤ 0,
- •Instrumental activities of daily living (IADL)=
- •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).
排除标准
- •Patient with identified neurological problems.
- •Patient with developing and/ or non-stabilized psychiatric disease.
- •Patient with biological disorders observed during diagnostic process.
结局指标
主要结局
Occurrence of dementia according to DSM-IV-TR criteria in MCI patients according to their cumulated score of TLE measured by EVVIE.
时间窗: 2 years
次要结局
未报告次要终点
研究者
Jean Pierre Clement
Professor of Psychiatry -Ph.D
Centre Hospitalier Esquirol