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

This study has been completed.
Sponsor:
Collaborators:
Caisse Nationale de Solidarité pour l'Autonomie
Caisse Nationale d'Assurance Maladie des Travailleurs Non Salariés
Direction Générale de la Santé, France
Institut National de la Santé Et de la Recherche Médicale, France
Université Victor Segalen Bordeaux 2
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00646269
First received: March 25, 2008
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive abilities (ADAS-cog) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Functional abilities in activities of daily living (DAD scale) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Behavioural disturbance (NPI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Apathy (Apathy Inventory) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of life (Quol-AD) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Depression (MADRS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 640
Study Start Date: March 2008
Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646269

Locations
France
CH Agen
Agen, France, 47923
CHU Amiens Nord
Amiens, France, 80054
Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux
Bordeaux, France, 33076
Hôpital Pellegrin
Bordeaux, France, 33076
CHU Côte de Nacre
Caen, France, 14033
Centre pour Personnes Agées
Colmar, France, 68020
Centre de Gériatrie
DAX, France, 40107
Hôpital Dupuytren
Draveil, France, 92210
Pôle de Gérontologie CHICAS
Gap, France, 05007
Les Fontaines de Monjous
Gradignan, France, 33170
CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble
Grenoble, France, 38043
Centre Hospitalier La Rochelle
La rochelle, France, 17000
Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "
La Seyne sur Mer, France, 83500
Centre Hospitalier de Libourne
Libourne, France, 33505
CHU Limoges
Limoges, France, 87042
Hôpital Privé Gériatrique Les Magnolias
Longjumeau, France, 91161
Centre Hospitalier Bretagne Sud
Lorient, France, 56322
Groupe Hospitalier Saint-Augustin
Malestroit, France, 56140
Hôpital Sainte-Marguerite
Marseille, France, 13009
Hôpital Gui de Chauliac
Montpellier, France, 34295
Centre Antonin Balmes
Montpellier, France, 34295
Clinique Neurologique, CHU Nord
Nantes, France, 44093
Centre Mémoire, Hôpital Pasteur,
Nice, France, 06002
Hôpital Broca
Paris, France, 75013
Hôpital de la Salpétrière,
Paris, France, 75013
Centre Hospitalier des Pyrénées
Pau, France, 64000
Hôpital de Jour Gériatrique
Pau, France, 64000
Hôpital Xavier-Arnozan
Pessac, France, 33604
CHI Poissy-saint-germain-en-laye
Poissy, France, 78300
Hôpital de Jour gériatrique
Poitiers, France, 86021
CHU de Rennes
Rennes, France, 35000
Hôpital de Jour Gériatrique
Saint Raphaël, France, 83700
CHRU de Saint-Etienne
Saint-Etienne, France, 42055
Centre hospitalier Ariège Couserans
Saint-Girons, France, 09201
Hôpitaux universitaires de Strasbourg
Strasbourg, France, 67091
Bagatelle
Talence, France, 33401
CHIC Marmande - Tonneins
Tonneins, France, 47400
CHU Purpan-Casselardit
Toulouse, France, 31300
Hôpital des Charpennes
Villeurbanne, France, 69100
Sponsors and Collaborators
University Hospital, Bordeaux
Caisse Nationale de Solidarité pour l'Autonomie
Caisse Nationale d'Assurance Maladie des Travailleurs Non Salariés
Direction Générale de la Santé, France
Institut National de la Santé Et de la Recherche Médicale, France
Université Victor Segalen Bordeaux 2
Investigators
Principal Investigator: Jean-François , Dartigues, MD, PhD University Hospital of Bordeaux
Study Chair: Geneviève Chêne, MD, PhD University Hospital of Bordeaux
  More Information

Publications:
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00646269     History of Changes
Other Study ID Numbers: 2007/17
Study First Received: March 25, 2008
Last Updated: July 31, 2013
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Bordeaux:
Dementia ; Alzheimer's Disease ; Non pharmacological treatments ; cognitive training ; reminiscence therapy ; efficacy assessment

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014