Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease
ETNA3
1 other identifier
interventional
640
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2008
Longer than P75 for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 1, 2013
July 1, 2013
2.8 years
March 25, 2008
July 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower)
2 years
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (4)
1
ACTIVE COMPARATOR2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTALInterventions
The control group involves a standardized medical follow-up of patients with Alzheimer's disease and a psychoeducative group program for caregivers of patients.
"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.
"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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Bordeauxlead
- Caisse Nationale de Solidarité pour l'Autonomiecollaborator
- National Health Insurance Fund for Unemployed Workerscollaborator
- Direction Générale de la Santé, Francecollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- Université Victor Segalen Bordeaux 2collaborator
Study Sites (39)
CH Agen
Agen, 47923, France
CHU Amiens Nord
Amiens, 80054, France
Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux
Bordeaux, 33076, France
Hôpital Pellegrin
Bordeaux, 33076, France
CHU Côte de Nacre
Caen, 14033, France
Centre pour Personnes Agées
Colmar, 68020, France
Centre de Gériatrie
Dax, 40107, France
Hôpital Dupuytren
Draveil, 92210, France
Pôle de Gérontologie CHICAS
Gap, 05007, France
Les Fontaines de Monjous
Gradignan, 33170, France
CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble
Grenoble, 38043, France
Centre Hospitalier La Rochelle
La Rochelle, 17000, France
Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "
La Seyne-sur-Mer, 83500, France
Centre Hospitalier de Libourne
Libourne, 33505, France
CHU Limoges
Limoges, 87042, France
Hôpital Privé Gériatrique Les Magnolias
Longjumeau, 91161, France
Centre Hospitalier Bretagne Sud
Lorient, 56322, France
Groupe Hospitalier Saint-Augustin
Malestroit, 56140, France
Hôpital Sainte-Marguerite
Marseille, 13009, France
Centre Antonin Balmes
Montpellier, 34295, France
Hôpital Gui de Chauliac
Montpellier, 34295, France
Clinique Neurologique, CHU Nord
Nantes, 44093, France
Centre Mémoire, Hôpital Pasteur,
Nice, 06002, France
Hôpital Broca
Paris, 75013, France
Hôpital de la Salpétrière,
Paris, 75013, France
Centre Hospitalier des Pyrénées
Pau, 64000, France
Hôpital de Jour Gériatrique
Pau, 64000, France
Hôpital Xavier-Arnozan
Pessac, 33604, France
CHI Poissy-saint-germain-en-laye
Poissy, 78300, France
Hôpital de Jour gériatrique
Poitiers, 86021, France
CHU de Rennes
Rennes, 35000, France
CHRU de Saint-Etienne
Saint-Etienne, 42055, France
Centre hospitalier Ariège Couserans
Saint-Girons, 09201, France
Hôpital de Jour Gériatrique
Saint-Raphaël, 83700, France
Hôpitaux universitaires de Strasbourg
Strasbourg, 67091, France
Bagatelle
Talence, 33401, France
CHIC Marmande - Tonneins
Tonneins, 47400, France
CHU Purpan-Casselardit
Toulouse, 31300, France
Hôpital des Charpennes
Villeurbanne, 69100, France
Related Publications (1)
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.
PMID: 14583963BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-François, Dartigues, MD, PhD
University Hospital, Bordeaux
- STUDY CHAIR
Geneviève Chêne, MD, PhD
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2008
First Posted
March 28, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2012
Last Updated
August 1, 2013
Record last verified: 2013-07