Cross-sectional Study for Cognitive and Genetic Characterization of a 45-65 Years Old Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,743
- 试验地点
- 1
- 主要终点
- Factors influencing the cognitive performance through demanding tests of episodic memory and executive function
研究概览
简要总结
Before Alzheimer's disease (AD) clinical symptoms appear, there is a long period when changes in the brain occur. In this long asymptomatic period or preclinical phase, studies with populations at risk of developing AD have shown cognitive differences compared to control groups without such risk. There is a need for short, sensitive, easily administered, reproducible, non-expensive and independent of socio-demographic influences tests enabling the detection of pre-symptomatic variations in memory, when the memory decline is still within a normal range.
Study main hypothesis: When evaluated with high-demanding tests of memory and executive function, the cognitive performance of cognitive healthy people aged between 45 and 65 and, extensively, to a group of up to 75 years, will vary significantly depending on clinical, socio-demographic and genetic features
详细描述
The purpose of Study 45-65 is to assess if:
- Endogenous factors (clinical history, risk factors, genetic factors APOE4, etc...), exogenous (socio-demographic, ambient and lifestyle variables) and cognitive reserve (including bilingualism) influence cognitive performance.
- New and/or updated tests translated and validated in Spanish and Catalan when needed, will provide accurate and sensitive measurements of the variability of cognitive performance in this target population, representative of the preclinical phase of Alzheimer's disease.
An optional visit is offered to study participants that includes: cerebral magnetic resonance, vascular ultrasound and olfactory testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, aged between 45 and 75 years
- •Spanish and/or Catalan speakers
- •Agreement with the study procedures and tests:
- •Clinical Interview and questionnaires associated to risk factors
- •Cognitive tests
- •Blood sample extraction for DNA analysis
- •Close relative involvement for functional evaluation of the volunteer
- •Signature of informed consent
排除标准
- •Cognitive impairment: MMSE <26, o MIS <6, or orientation subtest of the Barcelona Test II <68, o category fluency (animals) <12
- •Functional status impairment: CDR > 0
- •Severe auditory and/or visual impairment
- •Neurodevelopmental and/or psychomotor disorder
- •Significant diseases that could currently interfere with cognition: renal failure on hemodialysis, liver cirrhosis, chronic lung disease with oxygen therapy, solid organ transplantation, fibromyalgia, active cancer in treatment or any other disease the investigator considers could affect the participant cognition
- •Major psychiatric disorders (DSM-IV-TR) or diseases that could affect cognitive abilities: major depression, bipolar disorder, schizophrenia and dementia.
- •Neurological disorders: Parkinson's disease, stroke, epilepsy and treatment with frequent seizures (> 1/month) in the past year, multiple sclerosis or other serious neurological disease.
- •Brain injury interfering with cognition: history of head trauma with parenchymal lesion or extraaxial macroscopic large vessel ischemic stroke or hemorrhagic stroke, brain surgery, brain tumors and other causes that can generate acquired brain damage (cerebral chemotherapy or radiotherapy)
- •Family history of Alzheimer's disease with autosomal dominant (3 affected in two different generations) and early onset age (<60 years).
结局指标
主要结局
Factors influencing the cognitive performance through demanding tests of episodic memory and executive function
时间窗: single Visit (up to 3 hours)
The following tests will be administered: Verbal episodic memory: MBT (Memory Binding Test) WAIS-IV subsets: 1 Perceptual reasoning (Visual Puzzles) 2 Logical reasoning (Matrix Reasoning) 3 Executive attention and working memory (Digit span) 4 Speed of processing (Coding) 5 Abstract verbal reasoning (Similarities) Factors to be considered: Hypertension, diabetes mellitus, and metabolic syndrome APOE4 Cognitive reserve (including bilingualism) Pollution, exposure to toxics, diet
Culturally adapted validation in Spanish and Catalan of the MBT and determination of normative data for the population under study.
时间窗: single visit (up to 3 hours)
次要结局
- Identification of genetic determinants of neuroimaging phenotypes associated to Alzheimer's disease.(5 years and 8 months after study start)
- Assessment of the relationship between olfactory and cognitive performance(5 years and 8 months after study start)
- Assessment of the equivalence of the in person and over the phone administration to the close relative of the Clinical Dementia Rating (CDR).(single visit/telephone conversation (up to 10 min))
- Genetic features of the population(8 months after study start)
- Analysis of the relationship between subclinical atherosclerosis and brain changes, cognitive performance and APOE genotype(6 years and 8 months after study start)