MAPT STUDY: A MULTIDOMAIN APPROACH FOR PREVENTING ALZHEIMER'S DISEASE: DESIGN AND BASELINE DATA.-猫眼课题宝

DOI：

10.14283/jpad.2014.34

发表时间：

2014-05

期刊：

The journal of prevention of Alzheimer's disease

影响因子：

通讯作者：

中科院分区：

文献类型：

作者：

B. Vellas;I. Carrié;S. Gillette‐Guyonnet;J. Touchon;T. Dantoine;J. Dartigues;M. Cuffi;S. Bordes;Y. Gasnier;P. Robert;L. Bories;O. Rouaud;F. Desclaux;K. Sudres;M. Bonnefoy;A. Pesce;C. Dufouil;S. Lehéricy;M. Chupin;J. F. Mangin;P. Payoux;D. Adel;P. Legrand;D. Catheline;C. Kanony;M. Zaim;L. Molinier;N. Costa;J. Delrieu;T. Voisin;C. Faisant;F. Lala;F. Nourhashemi;Y. Rolland;G. A. van Kan;C. Dupuy;C. Cantet;P. Cestac;S. Belleville;S. Willis;M. Cesari;M. Weiner;M. Soto;P. Ousset;S. Andrieu

目的多领域阿尔茨海默病预防试验（MAPT研究）旨在评估单独补充omega-3脂肪酸、单独多领域干预（包括营养咨询、体育锻炼、认知刺激）或两种干预组合对70岁及以上体弱受试者认知功能改变的有效性，为期3年。此外还进行了辅助神经影像学研究，以评价干预对脑代谢（FDG PET扫描）和萎缩率（MRI）以及脑淀粉样存款（AV 45 PET扫描）的影响。设计患者1680名受试者（平均年龄：75.3岁;女性：64.8%），由13个记忆诊所招募，随机分为以下四组之一：单独补充omega-3，单独多领域干预，omega-3加多领域干预，或安慰剂。受试者在M6、M12、M24和M36访视时接受认知、功能和生物学评估。主要终点是3年时记忆功能的变化，通过自由和线索选择性提醒测试进行评估。所有受试者将在3年干预后再接受2年随访（MAPT PLUS扩展研究）。干预措施1/Omega-3补充剂：每天两个软胶囊作为单剂量，含有总共400 mg二十二碳六烯酸（DHA），即，每天800毫克二十二碳六烯酸，持续3年。2/多域干预：在最初的两个月里，以小组（6-8名参与者）的形式进行12次120分钟的集体培训（第一个月每周两次，第二个月每周一次），然后每月在以下三个领域进行60分钟的培训：营养、体育活动和认知，直到3年结束。除集体治疗外，还在基线、M12和M24时进行个体化预防性门诊访视，探索认知能力下降的可能风险因素。基线人群对于认知，基线时的平均MMSE为28.1（± 1.6）。大约58%和42%的参与者的CDR评分分别为0和0.5。关于活动性状态，200例（11.9%）的4 m步态速度低于或等于0.8 m/s。根据Fried标准，673名（42.1%）参与者被认为是虚弱前，51名（3.2%）虚弱。红细胞DHA含量为26.1 ± 8.1 µg/g。503名参与者接受了基线MRI。对271名患者进行了AV 45 PET扫描，初步结果显示38.0%的患者的皮质SUVR > 1.17，这表明存在大量脑淀粉样存款。讨论内容：MAPT试验是目前第一个最大和最长的多领域预防性试验，与有主观记忆投诉的老年人的认知下降有关。为MAPT试验设计的多领域干预可能很容易在一般人群中实施。

OBJECTIVE The Multidomain Alzheimer Preventive Trial (MAPT study) was designed to assess the efficacy of isolated supplementation with omega-3 fatty acid, an isolated multidomain intervention (consisting of nutritional counseling, physical exercise, cognitive stimulation) or a combination of the two interventions on the change of cognitive functions in frail subjects aged 70 years and older for a period of 3 years. Ancillary neuroimaging studies were additionally implemented to evaluate the impact of interventions on cerebral metabolism (FDG PET scans) and atrophy rate (MRIs), as well as brain amyloïd deposit (AV45 PET scans). DESIGN PATIENTS 1680 subjects (mean age: 75.3 years; female: 64.8 %), enrolled by 13 memory clinics, were randomized into one of the following four groups: omega-3 supplementation alone, multidomain intervention alone, omega-3 plus multidomain intervention, or placebo. Participants underwent cognitive, functional and biological assessments at M6, M12, M24 and M36 visits. The primary endpoint is a change of memory function at 3 years, as assessed by the Free and Cued Selective Reminding test. All participants will be followed for 2 additional years after the 3-years intervention (MAPT PLUS extension study). INTERVENTIONS 1/Omega-3 supplementation: two soft capsules daily as a single dose, containing a total of 400 mg docosahexaenoic acid (DHA), i.e., 800 mg docosahexaenoic acid per day, for 3 years. 2/ Multidomain intervention: collective training sessions conducted in small groups (6-8 participants) in twelve 120-minute sessions over the first 2 months (two sessions a week for the first month, and one session a week the second month) then a 60-minute session per month in the following three areas: nutrition, physical activity, and cognition until the end of the 3 years. In addition to the collective sessions, individualized preventive outpatient visits exploring possible risk factors for cognitive decline are performed at baseline, M12 and M24. BASELINE POPULATION For cognition, the mean MMSE at baseline was 28.1 (± 1.6). About 58% and 42% of participants had a CDR score equal to 0 and 0.5, respectively. Regarding mobility status, 200 (11.9%) had a 4-m gait speed lower or equal to 0.8 m/s. According to the Fried criteria, 673 (42.1%) participants were considered pre frail, and 51 (3.2%) frail. The red blood cell DHA content was 26.1 ± 8.1 µg/g. Five hundred and three participants underwent baseline MRI. AV45 PET scans were performed in 271 individuals and preliminary results showed that 38.0% had a cortical SUVR > 1.17, which gave an indication of significant brain amyloïd deposit. DISCUSSION: The MAPT trial is presently the first largest and longest multidomain preventive trial relevant to cognitive decline in older adults with subjective memory complaints. The multidomain intervention designed for the MAPT trial is likely to be easily implemented within the general population.

MAPT STUDY: A MULTIDOMAIN APPROACH FOR PREVENTING ALZHEIMER'S DISEASE: DESIGN AND BASELINE DATA.

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