Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease (ETNA3)

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.

Study Overview

• Status: Completed
• 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

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

• Study Type: Interventional
• Enrollment (Actual): 640
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Agen, France, 47923
    • CH Agen
  • Amiens, France, 80054
    • CHU Amiens Nord
  • Bordeaux, France, 33076
    • Hopital Pellegrin
  • Bordeaux, France, 33076
    • Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux
  • Caen, France, 14033
    • CHU côte de Nacre
  • Colmar, France, 68020
    • Centre Pour Personnes Agees
  • DAX, France, 40107
    • Centre de Gériatrie
  • Draveil, France, 92210
    • Hôpital Dupuytren
  • Gap, France, 05007
    • Pôle de Gérontologie CHICAS
  • Gradignan, France, 33170
    • Les Fontaines de Monjous
  • Grenoble, France, 38043
    • CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble
  • La Seyne sur Mer, France, 83500
    • Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "
  • La rochelle, France, 17000
    • Centre Hospitalier La Rochelle
  • Libourne, France, 33505
    • Centre Hospitalier de Libourne
  • Limoges, France, 87042
    • Chu Limoges
  • Longjumeau, France, 91161
    • Hôpital Privé Gériatrique Les Magnolias
  • Lorient, France, 56322
    • Centre Hospitalier Bretagne Sud
  • Malestroit, France, 56140
    • Groupe Hospitalier Saint-Augustin
  • Marseille, France, 13009
    • Hôpital Sainte-Marguerite
  • Montpellier, France, 34295
    • Hopital Gui de Chauliac
  • Montpellier, France, 34295
    • Centre Antonin Balmes
  • Nantes, France, 44093
    • Clinique Neurologique, CHU Nord
  • Nice, France, 06002
    • Centre Mémoire, Hôpital Pasteur,
  • Paris, France, 75013
    • Hopital Broca
  • Paris, France, 75013
    • Hôpital de la Salpétrière,
  • Pau, France, 64000
    • Centre Hospitalier des Pyrenees
  • Pau, France, 64000
    • Hôpital de Jour Gériatrique
  • Pessac, France, 33604
    • Hôpital Xavier-Arnozan
  • Poissy, France, 78300
    • CHI Poissy-saint-germain-en-laye
  • Poitiers, France, 86021
    • Hôpital de Jour Gériatrique
  • Rennes, France, 35000
    • CHU de Rennes
  • Saint Raphaël, France, 83700
    • Hôpital de Jour Gériatrique
  • Saint-Etienne, France, 42055
    • CHRU de Saint-Etienne
  • Saint-Girons, France, 09201
    • Centre hospitalier Ariège Couserans
  • Strasbourg, France, 67091
    • Hôpitaux Universitaires de Strasbourg
  • Talence, France, 33401
    • Bagatelle
  • Tonneins, France, 47400
    • CHIC Marmande - Tonneins
  • Toulouse, France, 31300
    • CHU Purpan-Casselardit
  • Villeurbanne, France, 69100
    • Hôpital des charpennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	Behavioral: Standard 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.
Experimental: 3	Behavioral: Standard 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.
Experimental: 4	Behavioral: Standard 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.
Active Comparator: 1	Behavioral: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Université Victor Segalen Bordeaux 2; Direction Générale de la Santé, France; Caisse Nationale de Solidarité pour l'Autonomie; National Health Insurance Fund for Unemployed Workers
• Investigators: Principal Investigator: Jean-François, Dartigues, MD, PhD, University Hospital, Bordeaux; Study Chair: Geneviève Chêne, MD, PhD, University Hospital, Bordeaux

Publications and helpful links

General Publications

• Clare L, Woods RT, Moniz Cook ED, Orrell M, Spector A. Cognitive rehabilitation and cognitive training for early-stage Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2003;(4):CD003260. doi: 10.1002/14651858.CD003260.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 25, 2008
• First Submitted That Met QC Criteria: March 25, 2008
• First Posted (Estimate): March 28, 2008

Study Record Updates

• Last Update Posted (Estimate): August 1, 2013
• Last Update Submitted That Met QC Criteria: July 31, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Dementia ; Alzheimer's Disease ; Non pharmacological treatments ; cognitive training ; reminiscence therapy ; efficacy assessment
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2007/17