Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease (ETNA3)
May 11, 2026 updated by: University Hospital, Bordeaux
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Agen, France, 47923
- CH Agen
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Amiens, France, 80054
- CHU Amiens Nord
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Bordeaux, France, 33076
- Hôpital Pellegrin
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Bordeaux, France, 33076
- Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux
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Caen, France, 14033
- CHU côte de Nacre
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Colmar, France, 68020
- Centre pour Personnes Âgées
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Dax, France, 40107
- Centre de Gériatrie
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Draveil, France, 92210
- Hopital Dupuytren
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Gap, France, 05007
- Pôle de Gérontologie CHICAS
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Gradignan, France, 33170
- Les Fontaines de Monjous
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Grenoble, France, 38043
- CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble
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La Rochelle, France, 17000
- Centre Hospitalier La Rochelle
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La Seyne-sur-Mer, France, 83500
- Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "
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Libourne, France, 33505
- Centre Hospitalier de Libourne
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Limoges, France, 87042
- CHU Limoges
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Longjumeau, France, 91161
- Hôpital Privé Gériatrique Les Magnolias
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Lorient, France, 56322
- Centre Hospitalier Bretagne Sud
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Malestroit, France, 56140
- Groupe Hospitalier Saint-Augustin
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Marseille, France, 13009
- Hôpital Sainte-Marguerite
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Montpellier, France, 34295
- Hopital Gui de Chauliac
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Montpellier, France, 34295
- Centre Antonin Balmes
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Nantes, France, 44093
- Clinique Neurologique, CHU Nord
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Nice, France, 06002
- Centre Mémoire, Hôpital Pasteur,
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Paris, France, 75013
- Hopital BROCA
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Paris, France, 75013
- Hôpital de la Salpétrière,
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Pau, France, 64000
- Centre Hospitalier des Pyrénées
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Pau, France, 64000
- Hôpital de Jour Gériatrique
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Pessac, France, 33604
- Hôpital Xavier-Arnozan
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Poissy, France, 78300
- CHI Poissy-saint-germain-en-laye
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Poitiers, France, 86021
- Hôpital de Jour Gériatrique
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Rennes, France, 35000
- CHU de Rennes
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Saint-Etienne, France, 42055
- CHRU de Saint-Etienne
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Saint-Girons, France, 09201
- Centre hospitalier Ariège Couserans
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Saint-Raphaël, France, 83700
- Hôpital de Jour Gériatrique
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Strasbourg, France, 67091
- Hopitaux Universitaires de Strasbourg
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Talence, France, 33401
- Bagatelle
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Tonneins, France, 47400
- CHIC Marmande - Tonneins
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Toulouse, France, 31300
- CHU Purpan-Casselardit
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Villeurbanne, France, 69100
- Hopital des Charpennes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2
|
"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.
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|
Experimental: 3
|
"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
|
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.
|
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Active Comparator: 1
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The control group involves a standardized medical follow-up of patients with Alzheimer's disease and a psychoeducative group program for caregivers of patients.
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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)
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cognitive abilities (ADAS-cog)
Time Frame: 2 years
|
2 years
|
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Functional abilities in activities of daily living (DAD scale)
Time Frame: 2 years
|
2 years
|
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Behavioural disturbance (NPI)
Time Frame: 2 years
|
2 years
|
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Apathy (Apathy Inventory)
Time Frame: 2 years
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2 years
|
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Quality of life (Quol-AD)
Time Frame: 2 years
|
2 years
|
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Depression (MADRS)
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean-François, Dartigues, MD, PhD, University Hospital, Bordeaux
- Study Chair: Geneviève Chêne, MD, PhD, University Hospital, Bordeaux
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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.
- Amieva H, Dartigues JF. ETNA3, a clinical randomized study assessing three cognitive-oriented therapies in dementia: rationale and general design. Rev Neurol (Paris). 2013 Oct;169(10):752-6. doi: 10.1016/j.neurol.2013.07.011. Epub 2013 Sep 4.
- Amieva H, Robert PH, Grandoulier AS, Meillon C, De Rotrou J, Andrieu S, Berr C, Desgranges B, Dubois B, Girtanner C, Joel ME, Lavallart B, Nourhashemi F, Pasquier F, Rainfray M, Touchon J, Chene G, Dartigues JF. Group and individual cognitive therapies in Alzheimer's disease: the ETNA3 randomized trial. Int Psychogeriatr. 2016 May;28(5):707-17. doi: 10.1017/S1041610215001830. Epub 2015 Nov 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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 (Estimated)
March 28, 2008
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2007/17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.