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Alzheimer's DiseasePhase 3ETNA3NCT00646269

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

A Phase 3 study testing Standard intervention protocol, Standard intervention protocol + Cognitive training therapy and Standard intervention protocol + Reminiscence therapy in people with Alzheimer's Disease, run by University Hospital, Bordeaux at 39 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Standard intervention protocol, Standard intervention protocol + Cognitive training therapy and Standard intervention protocol + Reminiscence therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
640 participants
Where
39 sitesFrance
Study dates
Mar 2008to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

France39 sites

  • CH Agen

    Agen, 47923

  • CHU Amiens Nord

    Amiens, 80054

  • Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux

    Bordeaux, 33076

  • Hôpital Pellegrin

    Bordeaux, 33076

  • CHU Côte de Nacre

    Caen, 14033

  • Centre pour Personnes Agées

    Colmar, 68020

  • Centre de Gériatrie

    Dax, 40107

  • Hôpital Dupuytren

    Draveil, 92210

  • Pôle de Gérontologie CHICAS

    Gap, 05007

  • Les Fontaines de Monjous

    Gradignan, 33170

  • CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble

    Grenoble, 38043

  • Centre Hospitalier La Rochelle

    La Rochelle, 17000

  • Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "

    La Seyne-sur-Mer, 83500

  • Centre Hospitalier de Libourne

    Libourne, 33505

  • CHU Limoges

    Limoges, 87042

  • Hôpital Privé Gériatrique Les Magnolias

    Longjumeau, 91161

  • Centre Hospitalier Bretagne Sud

    Lorient, 56322

  • Groupe Hospitalier Saint-Augustin

    Malestroit, 56140

  • Hôpital Sainte-Marguerite

    Marseille, 13009

  • Centre Antonin Balmes

    Montpellier, 34295

  • Hôpital Gui de Chauliac

    Montpellier, 34295

  • Clinique Neurologique, CHU Nord

    Nantes, 44093

  • Centre Mémoire, Hôpital Pasteur,

    Nice, 06002

  • Hôpital Broca

    Paris, 75013

  • Hôpital de la Salpétrière,

    Paris, 75013

  • Centre Hospitalier des Pyrénées

    Pau, 64000

  • Hôpital de Jour Gériatrique

    Pau, 64000

  • Hôpital Xavier-Arnozan

    Pessac, 33604

  • CHI Poissy-saint-germain-en-laye

    Poissy, 78300

  • Hôpital de Jour gériatrique

    Poitiers, 86021

  • CHU de Rennes

    Rennes, 35000

  • CHRU de Saint-Etienne

    Saint-Etienne, 42055

  • Centre hospitalier Ariège Couserans

    Saint-Girons, 09201

  • Hôpital de Jour Gériatrique

    Saint-Raphaël, 83700

  • Hôpitaux universitaires de Strasbourg

    Strasbourg, 67091

  • Bagatelle

    Talence, 33401

  • CHIC Marmande - Tonneins

    Tonneins, 47400

  • CHU Purpan-Casselardit

    Toulouse, 31300

  • Hôpital des Charpennes

    Villeurbanne, 69100

Other trials in France

About this study

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.

Read the 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

Being tested
Standard intervention protocol, Standard intervention protocol + Cognitive training therapy, Standard intervention protocol + Reminiscence therapy, Standard intervention protocol + "Made-to-measure" program
Keywords
Dementia ; Alzheimer's Disease ; Non pharmacological treatments ; cognitive training ; reminiscence therapy ; efficacy assessment
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard intervention protocolBehavioural

    The control group involves a standardized medical follow-up of patients with Alzheimer's disease and a psychoeducative group program for caregivers of patients.

  • Standard intervention protocol + Cognitive training therapyBehavioural

    "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.

  • Standard intervention protocol + Reminiscence therapyBehavioural

    "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.

  • Standard intervention protocol + "Made-to-measure" programBehavioural

    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.

Study groups in NCT00646269
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Behavioral: Standard intervention protocol
2ExperimentalNot described
Receives: Behavioral: Standard intervention protocol + Cognitive training therapy
3ExperimentalNot described
Receives: Behavioral: Standard intervention protocol + Reminiscence therapy
4ExperimentalNot described
Receives: Behavioral: Standard intervention protocol + "Made-to-measure" program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower)

    Measured: 2 years

Secondary outcomes (6)

  1. Cognitive abilities (ADAS-cog)

    Measured: 2 years

  2. Functional abilities in activities of daily living (DAD scale)

    Measured: 2 years

  3. Behavioural disturbance (NPI)

    Measured: 2 years

  4. Apathy (Apathy Inventory)

    Measured: 2 years

  5. Quality of life (Quol-AD)

    Measured: 2 years

  6. Depression (MADRS)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionDec 2010
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
640 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00646269
Sponsor's protocol ID
CHUBX 2007/17
Acronym
ETNA3
Status last verified
Jul 2013
First submitted
25 Mar 2008
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 14583963

  • 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.

    PubMed 24011983

  • 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.

    PubMed 26572551

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Standard intervention protocol, Standard intervention protocol + Cognitive training therapy and Standard intervention protocol + Reminiscence therapy in people with Alzheimer's Disease, run by University Hospital, Bordeaux at 39 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00646269, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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