Hélène Amieva1, Philippe H Robert2, Anne-Sophie Grandoulier3, Céline Meillon4, Jocelyne De Rotrou5, Sandrine Andrieu6, Claudine Berr7, Béatrice Desgranges8, Bruno Dubois9, Chantal Girtanner10, Marie-Eve Joël11, Benoit Lavallart12, Fati Nourhashemi6, Florence Pasquier13, Muriel Rainfray4, Jacques Touchon7, Geneviève Chêne1, Jean-François Dartigues1. 1. INSERM,U897-Epidemiology-Biostatistics,University of Bordeaux,F-33076,Bordeaux,France. 2. CHU Nice,Memory Center of Nice (Centre Mémoire de Ressources et de Recherche),France. 3. CHU Bordeaux,Pôle de Santé Publique,USMR and CIC-EC 7,F-33000,Bordeaux,France. 4. CHU Bordeaux,Memory Center of Bordeaux (Centre Mémoire de Ressources et de Recherche),France. 5. AP-HP,Hôpital Broca,Service de Gérontologie,F-75013,Paris,France. 6. INSERM,UMR1027,University of Toulouse III,F-31000,Toulouse,France. 7. INSERM,UMR 1061,University of Montpellier,F-33400 Montpellier,France. 8. INSERM,U1077,Université de Caen Basse-Normandie,Ecole Pratique des Hautes Etudes,CHU de Caen,France. 9. INSERM UMR S975,Hôpital de la Salpêtrière,F-75651 Paris cedex 13,France. 10. CHU de Saint-Étienne,Hôpital Charité,Service de gérontologie clinique,France. 11. University of Paris-Dauphine,Laboratoire d'Economie et de Gestion des Organisations de Santé (LEDa-LEGOS),Paris,France. 12. Direction Générale de la Santé,Paris,France. 13. CHU Lille,Memory Center of Lille (Centre Mémoire de Ressources et de Recherche),France.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: These findings challenge current management practices of Alzheimer'spatients. 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.
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