Ageing stereotypes and prodromal Alzheimer's disease (AGING): study protocol for an ongoing randomised clinical study
Ageing stereotypes and prodromal Alzheimer's disease (AGING): study protocol for an ongoing randomised clinical study
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DOI：
10.1136/bmjopen-2019-032265
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发表时间：
2019-10-01
期刊：
影响因子：
2.9
通讯作者：
Mazerolle, Marie
中科院分区：
文献类型：
--
作者：
Gauthier, Kim;Morand, Alexandrine;Mazerolle, Marie
简介 全球范围内，被诊断患有遗忘性轻度认知障碍 (aMCI)（阿尔茨海默病 (AD) 的前驱状态）的老年人数量正在增加。然而，一些 aMCI 患者从未转化为 AD 型痴呆，其中一些患者保持稳定，另一些则恢复正常。这种过度诊断偏差在很大程度上被忽视并且无法解释。实验室中有充分的证据表明，消极的衰老刻板印象（例如，文化上共同的信念，即衰老不可避免地导致严重的认知能力下降）会导致健康老年人的认知能力恶化，导致他们的表现低于其真实能力。这里描述的研究旨在首次测试这种刻板印象是否也会损害患者在记忆诊所的神经心理学检查期间的认知表现，从而导致aMCI的过度诊断。 方法和分析正在进行的研究是一项为期4年的随机临床试验，比较患者在记忆诊所的神经心理学测试期间的生理压力和认知表现。总共 260 名参加第一次认知评估的患者将被随机分配到标准测试条件（这里假设隐含地激活消极的衰老刻板印象）或减少威胁指导条件（旨在减轻这些刻板印象产生的焦虑）。两组都将使用相同的测试电池和压力生物标志物进行测试。对于每组中诊断为 aMCI 的 30 名患者 (n=60)，将使用神经变性和淀粉样变性生物标志物来区分具有正常与异常 AD 生物标志物的 aMCI。将对所有患者进行为期 9 个月的随访，以确定认知表现保持稳定、恶化或改善的患者。 伦理与传播 本方案已获得法国国家药品和保健品安全局和 Sud-Est I 法国伦理委员会批准 (2017-A00946-47)。结果将发表在同行评审的期刊上。
Introduction The number of older people diagnosed with amnestic mild cognitive impairment (aMCI), the prodromal state of Alzheimer's disease (AD), is increasing worldwide. However, some patients with aMCI never convert to the AD type of dementia, with some remaining stable and others reverting to normal. This overdiagnosis bias has been largely overlooked and gone unexplained. There is ample evidence in the laboratory that negative ageing stereotypes (eg, the culturally shared belief that ageing inescapably causes severe cognitive decline) contribute to the deteriorating cognitive performances of healthy older adults, leading them to perform below their true abilities. The study described here is intended to test for the first time whether such stereotypes also impair patients' cognitive performances during neuropsychological examinations in memory clinics, resulting in overdiagnosis of aMCI.Methods and analysis The ongoing study is a 4-year randomised clinical trial comparing patients' physiological stress and cognitive performances during neuropsychological testing in memory clinics. A total of 260 patients attending their first cognitive evaluation will be randomised to either a standard condition of test administration, assumed here to implicitly activate negative ageing stereotypes or a reduced-threat instruction condition designed to alleviate the anxiety arising from these stereotypes. Both groups will be tested with the same test battery and stress biomarkers. For 30 patients diagnosed with aMCI in each group (n=60), biomarkers of neurodegeneration and amyloidopathy will be used to distinguish between aMCI with normal versus abnormal AD biomarkers. A 9-month follow-up will be performed on all patients to identify those whose cognitive performances remain stable, deteriorate or improve.Ethics and dissemination This protocol has been approved by the French National Agency for Medicines and Health Products Safety and the Sud-Est I French Ethics Committee (2017-A00946-47). Results will be published in peer-reviewed journals.