A Longitudinal Population Study on Brain Aging and Mental Performances for the 1935-1939 Born People Living in Abbiategrasso (a Small Town Near Milan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,321
- 试验地点
- 1
- 主要终点
- The proportion of the recruited persons who will develop Dementia syndrome, Alzheimer disease, Vascular dementia, Lewy Body dementia, frontotemporal dementia, Mild Cognitive Impairment, Cognitive Impairment No Dementia
研究概览
简要总结
Longitudinal observational study of cognitive functions, physical health and biological parameters in the whole population living in Abbiategrasso born between 1935 and 1939,1773 subjects, followed for six years in order to know the prevalence and the incidence of dementia and risk and protective factors of normal and pathological mental aging.
The peculiarities of this study that must assure the outcome efficacy are:
- Selected age: since 70-75 years old people represents a transition age from adulthood to old age, it is of special interest to study the evolution of psychic and physical functions of this population
- Whole population not a sample study
- Location: the small area involved (Abbiategrasso is a town of 30.000 inhabitants)can contribute to guarantee more homogeneity among the subjects and reduce undesired variability
- multidimensional assessment(biological, clinical, social, psychological data collected) After initial screening, the recruited population will be followed up for two more times (every two years )
详细描述
Background:
Dementia is one of the most troubling neurodegenerative syndrome whose prevalence and incidence is strongly increasing. The etiology and physiopathology of the process that causes dementia are still controversial and largely unknown. So it is of paramount importance to isolate risk and protection factors related to dementia syndrome and Alzheimer disease. These meager known factors (biological, as well as social and neuropsychological) can be better investigated through a multidimensional longitudinal study in a homogeneous population by age and place.
Method:
People belonging to the selected population (1773 subjects living in Abbiategrasso and born between 1935 - 1939) were invited to participate at a comprehensive assessment which was divided in two appointments:
- a first appointment (about 1 hour and half) for blood sample, social questionnaire, anthropometric and walking speed evaluation ;
- a second one (2 hours)for clinical examination and neuropsychological assessment of mood and cognitive function.
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
- 70 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to be resident in Abbiategrasso
- •to be born between 1935 and 1939
排除标准
- •to refuse to participate
- •te be not contactable in any way (mail, telephone)
- •to be legally resident, but actually living somewhere else
结局指标
主要结局
The proportion of the recruited persons who will develop Dementia syndrome, Alzheimer disease, Vascular dementia, Lewy Body dementia, frontotemporal dementia, Mild Cognitive Impairment, Cognitive Impairment No Dementia
时间窗: six years
These are the criteria used for the definitions : * DSM IV for Dementia syndrome * NINCDS ADRDA diagnostic criteria for Alzheimer disease * NINDS -AIREN criteria for Vascular dementia * Third report, DLB consortium for Lewy Body dementia * 2002 modified Consensus Conference criteria for frontotemporal dementia * Report of the MCI Working Group of the European Consortium on Alzheimer's Disease for Mild Cognitive Impairment (MCI) * Absence of the first criteria for MCI (subjective complain) for the definition of Cognitive Impairment No Dementia (CIND)
次要结局
- The proportion of persons who will exhibit a performance decrease equal or more than of 1,5 standard deviation of the mean in the reference population in screening cognitive tests or in memory tests (verbal and visual memory) or in executive tests(six years)
- Genetic baseline features of the persons who will developed dementia and/or cognitive impairment(six years)
- Neuropsychological baseline features of the persons who will develop dementia or cognitive impairment(six years)
- Clinical baseline features of the persons who will develop dementia or cognitive impairment(six years)
- Social baseline features of the persons who will developed dementia or cognitive impairment(six years)
研究者
Antonio Guaita, MD
director
Fondazione Golgi Cenci