Amieva Hélène, Robert Philippe H, Grandoulier Anne-Sophie, Meillon Céline, De Rotrou Jocelyne, Andrieu Sandrine, Berr Claudine, Desgranges Béatrice, Dubois Bruno, Girtanner Chantal, Joël Marie-Eve, Lavallart Benoit, Nourhashemi Fati, Pasquier Florence, Rainfray Muriel, Touchon Jacques, Chêne Geneviève, Dartigues Jean-François
INSERM,U897-Epidemiology-Biostatistics,University of Bordeaux,F-33076,Bordeaux,France.
CHU Nice,Memory Center of Nice (Centre Mémoire de Ressources et de Recherche),France.
Int Psychogeriatr. 2016 May;28(5):707-17. doi: 10.1017/S1041610215001830. Epub 2015 Nov 17.
Although non-drug interventions are widely used in patients with Alzheimer's disease, few large scale randomized trials involving a long-term intervention and several cognitive-oriented approaches have been carried out. ETNA3 trial compares the effect of cognitive training, reminiscence therapy, and an individualized cognitive rehabilitation program in Alzheimer's disease to usual care.
This is a multicenter (40 French clinical sites) randomized, parallel-group trial, with a two-year follow-up comparing groups receiving standardized programs of cognitive training (group sessions), reminiscence therapy (group sessions), individualized cognitive rehabilitation program (individual sessions), and usual care (reference group). Six hundred fifty-three outpatients with Alzheimer's disease were recruited. The primary efficacy outcome was the rate of survival without moderately severe to severe dementia at two years. Secondary outcomes were cognitive impairment, functional disability, behavioral disturbance, apathy, quality of life, depression, caregiver's burden, and resource utilization.
No impact on the primary efficacy measure was evidenced. For the two group interventions (i.e. cognitive training and reminiscence), none of the secondary outcomes differed from usual care. The larger effect was seen with individualized cognitive rehabilitation in which significantly lower functional disability and a six-month delay in institutionalization at two years were evidenced.
These findings challenge current management practices of Alzheimer's patients. While cognitive-oriented group therapies have gained popularity, this trial does not show improvement for the patients. The individualized cognitive rehabilitation intervention provided clinically significant results. Individual interventions should be considered to delay institutionalization in Alzheimer's disease.
尽管非药物干预在阿尔茨海默病患者中广泛应用,但涉及长期干预和多种认知导向方法的大规模随机试验却很少开展。ETNA3试验比较了认知训练、回忆疗法和个体化认知康复项目对阿尔茨海默病患者的效果与常规护理的效果。
这是一项多中心(40个法国临床地点)随机平行组试验,进行为期两年的随访,比较接受标准化认知训练项目(小组课程)、回忆疗法(小组课程)、个体化认知康复项目(个体课程)和常规护理(参照组)的各组情况。招募了653名阿尔茨海默病门诊患者。主要疗效指标是两年时无中度至重度痴呆的生存率。次要指标包括认知障碍、功能残疾、行为障碍、冷漠、生活质量、抑郁、照料者负担和资源利用情况。
未证实对主要疗效指标有影响。对于两组干预措施(即认知训练和回忆疗法),次要指标与常规护理相比均无差异。个体化认知康复显示出较大效果,其中功能残疾显著降低,两年时机构化延迟了6个月。
这些发现对当前阿尔茨海默病患者的管理实践提出了挑战。虽然认知导向的团体治疗已受到欢迎,但该试验并未显示对患者有改善作用。个体化认知康复干预产生了具有临床意义的结果。应考虑采用个体干预措施来延缓阿尔茨海默病患者的机构化。