Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease

Study Overview
=================
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

Official Title
-----------------
Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Behavioral: Standard intervention protocol
* Behavioral: Standard intervention protocol + Cognitive training therapy
* Behavioral: Standard intervention protocol + Reminiscence therapy
* Behavioral: Standard intervention protocol + Made-to-measure program


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Behavioral: Standard intervention protocol<br>* The control group involves a standardized medical follow-up of patients with Alzheimer's disease and a psychoeducative group program for caregivers of patients.<br>|
| Experimental: 2<br> | Behavioral: Standard intervention protocol + Cognitive training therapy<br>* 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.<br>|
| Experimental: 3<br> | Behavioral: Standard intervention protocol + Reminiscence therapy<br>* 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.<br>|
| Experimental: 4<br> | Behavioral: Standard intervention protocol + Made-to-measure program<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia ; Alzheimer's Disease ; Non pharmacological treatments ; cognitive training ; reminiscence therapy ; efficacy assessment