NCT02492529已完成不适用
Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease
Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Improvement of recognition memory accuracy measures under the familiarity condition as compared with the novel condition in the AD-MCI group
研究概览
简要总结
Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.
详细描述
Prospective functional Magnetic Resonance Imaging study involving a group of participants with Mild Cognitive Impairment due to AD and a control participants group matched for age, education level, verbal Intelligence Quotient as assessed through the French version of the National Adult Reading Test and income group following National Institute of Statistics and Economics Studies classification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers (pilot phase)
- •Aged 25 - 75
- •French native speakers
- •Right-handed
- •Education level equal or superior to primary school leaving certificate
- •Free from any medical or psychiatric condition that may impact cognition
- •Having given written informed consent
- •Volunteers (experimental phase)
- •Aged 60 - 75
- •French native speakers
- •Right-handed
- •Education level equal or superior to primary school leaving certificate
- •Free from any medical or psychiatric condition that may impact cognition
- •Having given written informed consent
- •AD-MCI participants
- •Aged 60 - 75
- •French native speakers
- •Right-handed
- •Education level equal or superior to primary school leaving certificate
- •Fulfilling criteria for " AD-MCI " (Albert et al., 2011)
- •Have been seen in a memory medical center or in Memory Resources and Research Medical Center for cognitive symptoms
- •Free from any medical or psychiatric condition that may impact cognition
- •Able to understand and consent
- •Having given written informed consent
排除标准
- •MRI contraindications (all participants)
- •Claustrophobia
- •Wearing of any metal implant such as:
- •Heart pacemaker
- •Iron-magnetic surgical clips
- •Any metallic foreign body in the eye or brain
- •Other criteria (all participants)
- •Significant history of neurological or psychiatric disorders
- •Ongoing medication that may affect cognitive performances
- •Sensory deficit that may interfere with the experimental design (e.g. uncorrected visual impairment)
- •Lack of sufficient cooperation during the cognitive tasks
- •Persons under major legal protection and/or deprived of liberty
- •Other criteria (control participants)
- •Global cognitive impairment attested by Mattis Dementia Rating Scale or Mini-Mental State Examination, according to available normative data
- •Other criteria (AD-MCI participants)
- •7 items modified Hachinski ischemic score > 2 (Hachinski et al., 2012)
- •Dementia (McKahn, et al., 2011)
结局指标
主要结局
Improvement of recognition memory accuracy measures under the familiarity condition as compared with the novel condition in the AD-MCI group
时间窗: 3 months
Significant effect of the familiarity vs novelty condition on the pattern of % BOLD signal change in across the brain in the AD-MCI group
时间窗: 3 months
次要结局
- Predictive validity of the brain % BOLD signal change pattern for participants clinical status (i.e. controls vs. AD-MCI)(3 months)
- Significant group effect on the pattern of % BOLD signal change in across the brain(3 months)
- Significant interaction between the kind of familiarity condition (i.e. novel, experimental or pre-experimental) and the estimates of recognition memory processes efficiency (i.e. respective contributions of recollection and familiarity, % correct)(3 months)
研究者
研究点 (2)
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