Alzheimer's Disease
Conditions
Keywords
Dementia ; Alzheimer's Disease ; Non pharmacological treatments ; cognitive training ; reminiscence therapy ; efficacy assessment
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALStandard intervention protocol
The control group involves a standardized medical follow-up of patients with Alzheimer's disease and a psychoeducative group program for caregivers of patients.
BEHAVIORALStandard intervention protocol + Cognitive training therapy
"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.
BEHAVIORALStandard intervention protocol + Reminiscence therapy
"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.
BEHAVIORALStandard intervention protocol + "Made-to-measure" program
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.
Sponsors
University Hospital, Bordeaux
Caisse Nationale de Solidarité pour l'Autonomie
National Health Insurance Fund for Unemployed Workers
Direction Générale de la Santé, France
Institut National de la Santé Et de la Recherche Médicale, France
Université Victor Segalen Bordeaux 2
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients in the mild to moderate stages of Alzheimer's Disease : MMSE score between 16 and 26 ; and stages 3 to 5 of the Global Deterioration Scale * Patients over 50 years of age * Patients with social security affiliation
Exclusion criteria
* Patients suffering other type of dementia * Institutionalized patients * Patients with psychiatric disorder * Patients with severe pathology in the terminal stages * Patients receiving non pharmacological therapies other than that proposed in the study * Enrollment in a pharmacological trial in the first 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower) | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive abilities (ADAS-cog) | 2 years |
| Functional abilities in activities of daily living (DAD scale) | 2 years |
| Behavioural disturbance (NPI) | 2 years |
| Apathy (Apathy Inventory) | 2 years |
| Quality of life (Quol-AD) | 2 years |
| Depression (MADRS) | 2 years |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJean-François, Dartigues, MD, PhD
University Hospital, Bordeaux
STUDY_CHAIRGeneviève Chêne, MD, PhD
University Hospital, Bordeaux
Outcome results
None listed