跳至主要内容
临床试验/NCT05481749
NCT05481749招募中不适用

Neuropsychological Assessment Of The Non-institutionalized Oldest-Old Population. Multicenter Normative Study.

Consorci Sanitari de l'Alt Penedès i Garraf6 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
6
主要终点
Cognitive Performance

研究概览

简要总结

Neuropsychological tests currently considered to evaluate the cognitive performance of the oldest-old population (more than 80 years) are not adapted to this group population. This trial aims to determine the normal limits for this group population of a set of 18 neuropsychological test. Results may improve the diagnostic cognitive evaluation of this population.

详细描述

120 subjects more than 80y old (non-institutionalized) grouped in 4 age categories (80-84, 85-89, 90-94, 95 or more) will be evaluated through 18 neuropsychological tests (usually considered at Memory Clinics).

Subjects will be recruited from 5 Primary Care Centers by a random selection method (stratified by age group).

Normal limits will be defined by the percentiles of test punctuation. Previously, punctuation will be adjusted by age and education level by lineal regression.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
80 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 80 or more years old
  • Residence at Comarca del Garraf
  • Able to be transfered to study center
  • Sufficient reading and writing capacity to carry out the neuropsychological tests, at the evaluator's discretion.

排除标准

  • Patient at end-of-life situation or with a very short life expectancy (days-weeks).
  • Hospital admission in the previous 3 months.
  • History of relevant mental illness: major depression, psychosis, bipolar disorder, obsessive-compulsive disorder.
  • Disease of the central nervous system with possible cognitive impairment: Parkinson's disease, multiple sclerosis, brain tumor, stroke with cognitive impairment, epilepsy, severe traumatic brain injury.
  • History of alcoholism or substance abuse.
  • Severe sensory deficit that prevents performing neuropsychological tests, at the discretion of the evaluator.
  • Positive Shortened Spanish Informant Questionnaire for Cognitive Decline in the Elderly questionnaire (SS-IQCODE) or Lobo's Cognitive Mini-examination Test (spanish adaptation of Minimental of Folstein test) with a score < 23 (20 in people with low schooling or illiteracy).
  • Dementia criteria according to the Diagnostic and Statistical Manual of Mental Disorders IV.

结局指标

主要结局

Cognitive Performance

时间窗: This outcome will be evaluated at Memory Clinic Unit, following the enrollment visit. The evaluation of this outcome will last approximately 60 minutes.

Cognitive performance will be evaluated by 18 neuropsychological test (quantitative scores) which cover all main cognitive domains (memory and learning, language, perceptual-motor abilities, executive functions and attention).

次要结局

未报告次要终点

研究者

发起方
Consorci Sanitari de l'Alt Penedès i Garraf
申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验