ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact of cognitive training, reminiscence therapy and a "made-to-measure" program on the progression rate of dementia.
ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact of non pharmacological treatments on the progression rate of dementia: Three non pharmacological treatments are being studied: cognitive training therapy, reminiscence therapy and a "made-to-measure" program. Nearly 40 "Memory Clinics" are participating. 800 patients suffering Alzheimer's Disease in the mild to moderate stage of the disease will be included. For each therapy, a standard intervention protocol has been defined. The main objective is to determine whether any or several of these non pharmacological treatments can delay the severe stage of dementia during a 2-year follow-up. The secondary outcomes assess cognitive abilities, functional abilities in activities of daily living, behavioural disturbance, apathy, quality of life, depression, caregiver burden and resource utilization
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
640
The control group involves a standardized medical follow-up of patients with Alzheimer's disease and a psychoeducative group program for caregivers of patients.
"Cognitive training therapy" is provided in small groups of 5 to 8 patients. It consists in classroom type sessions designed to provide general cognitive stimulation. A set of standard cognitive exercises (involving memory, attention, or problem-solving…) related to activities of daily living is realized at each session.
Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower)
Time frame: 2 years
Cognitive abilities (ADAS-cog)
Time frame: 2 years
Functional abilities in activities of daily living (DAD scale)
Time frame: 2 years
Behavioural disturbance (NPI)
Time frame: 2 years
Apathy (Apathy Inventory)
Time frame: 2 years
Quality of life (Quol-AD)
Time frame: 2 years
Depression (MADRS)
Time frame: 2 years
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"Reminiscence therapy" is provided in small groups of 5 to 8 patients. This therapy involves the discussion of past activities, events and experiences enhanced by aids such as photographs, familiar items, songs, or personal recordings. A particular topic of life (i.e. a wedding) is discussed at each session.
The "made to measure" program involves no systematic intervention. The psychologist is asked to choose among the two possible therapies ("Cognitive training therapy" or "Reminiscence therapy") the one more suitable for the patient after considering his clinical characteristics including socio-demographic characteristics, disease severity or cognitive and behavioural disturbance. It is an individualized approach emphasizing the importance of flexibility to allow adjustment to individual needs.
CH Agen
Agen, France
CHU Amiens Nord
Amiens, France
Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux
Bordeaux, France
Hôpital Pellegrin
Bordeaux, France
CHU Côte de Nacre
Caen, France
Centre pour Personnes Agées
Colmar, France
Centre de Gériatrie
Dax, France
Hôpital Dupuytren
Draveil, France
Pôle de Gérontologie CHICAS
Gap, France
Les Fontaines de Monjous
Gradignan, France
...and 29 more locations