Prevalence, Characteristics and Risk Factors of HIV-Associated Neurocognitive Disorders in Subjects Between the Ages of 55 and 70 Years: An Exposed/Unexposed Cross Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 12
- 主要终点
- The Prevalence of Neurocognitive troubles HAND in the HIV-infected and to compare it with the prevalence in the HIV-unexposed population in the CONSTANCES cohort.
研究概览
简要总结
The primary objective is to measure the prevalence of according to the Frascati classification in a HIV-infected population aged between 55 and 70 years (exposed group) and to compare it with the prevalence of HIV-Associated Neurocognitive Disorders (HAND) in unexposed subjects from the general population-based cohort CONSTANCES, matching subjects on age, gender, geographical origin and socioprofessional category.
详细描述
Secondary objectives are:
- To study factors associated with Asymptomatic Neurocognitive Impairment (ANI) or Mild Neurocognitive Disorders (MND) by distinguishing the impact of traditional risk factors of neurocognitive impairment and those related to HIV infection,
- To compare in the exposed and unexposed population physical characteristics, complaints and comorbidities,
- To compare global neurocognitive scores in both populations after standardized normal reduction of each test.
Methodology:
HIV-infected subjects aged between 55 and 70 years will be recruited in centres that support people who living with HIV usually. The study will be proposed consecutively to all subjects aged between 55 and 70 year. A brief inquiry will collect motives on subjects that refuse to participate. A minimum of 70 subjects by 5 years age categories will be included. Unexposed subjects will be recruited in the same regions as their HIV-infected counterparts from the CONSTANCES database, a general population health cohort, after random selection matched on age, gender, geographical origin and socioprofessional category (2 HIV-unexposed subjects for 1 exposed subject). Data collection will follow the same methods as in the CONSTANCES cohort, in particular the neurocognitive tests by trained neuropsychologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HIV subjects
-
Evaluation of health-related quality of life and collection of social and demographic informations at the inclusion visit.
-
Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at the neurocognitive visit.
-
Two substudies will be proposed:
-
cerebral images sub-study (80 patients in the centers of Montpellier and the centers of Nîmes)
-
sub-study on immune activating markers with sample's collection (plasma), 85 patients in the centers of Montpellier and the centers of Nîmes.
干预措施: Health related quality of life and social and demographic informations (Other)
HIV subjects
-
Evaluation of health-related quality of life and collection of social and demographic informations at the inclusion visit.
-
Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at the neurocognitive visit.
-
Two substudies will be proposed:
-
cerebral images sub-study (80 patients in the centers of Montpellier and the centers of Nîmes)
-
sub-study on immune activating markers with sample's collection (plasma), 85 patients in the centers of Montpellier and the centers of Nîmes.
干预措施: Neurocognitive assessment (Other)
HIV subjects
-
Evaluation of health-related quality of life and collection of social and demographic informations at the inclusion visit.
-
Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at the neurocognitive visit.
-
Two substudies will be proposed:
-
cerebral images sub-study (80 patients in the centers of Montpellier and the centers of Nîmes)
-
sub-study on immune activating markers with sample's collection (plasma), 85 patients in the centers of Montpellier and the centers of Nîmes.
干预措施: cerebral images sub-study (Radiation)
结局指标
主要结局
The Prevalence of Neurocognitive troubles HAND in the HIV-infected and to compare it with the prevalence in the HIV-unexposed population in the CONSTANCES cohort.
时间窗: at month 3 (neurocognitive evaluation)
Neurocognitive assessment with neuropsychologist and walking speed, grasp force and one leg stand assessments at month 3 (the neurocognitive visit).
次要结局
- A comparison of a global cognitive score in both populations after standardized normal reduction of each test.(at month 3 (neurocognitive evaluation))
- The prevalence of Asymptomatic Neurocognitive Impairment (ANI)(at month 3 (neurocognitive evaluation))
- The prevalence of Mild Neurocognitive Disorder (MND)(at month 3 (neurocognitive evaluation))
- Cognitive score distributions untreated or after transformation according to their distribution characteristics(at month 3 (neurocognitive evaluation))
- The prevalence of HIV-Associated Dementia(HAD)(at month 3 (neurocognitive evaluation))
- Physical score distributions untreated or after transformation according to their distribution characteristics(at month 3 (neurocognitive evaluation))