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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Standard intervention protocol
Standard intervention protocol + Cognitive training therapy
Standard intervention protocol + Reminiscence therapy
Standard intervention protocol + "Made-to-measure" program
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Dementia ; Alzheimer's Disease ; Non pharmacological treatments ; cognitive training ; reminiscence therapy ; efficacy assessment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH Agen
  • CHU Amiens Nord
  • Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux
  • Hôpital Pellegrin
  • CHU Côte de Nacre
  • Centre pour Personnes Agées
  • Centre de Gériatrie
  • Hôpital Dupuytren
  • Pôle de Gérontologie CHICAS
  • Les Fontaines de Monjous
  • CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble
  • Centre Hospitalier La Rochelle
  • Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "
  • Centre Hospitalier de Libourne
  • CHU Limoges
  • Hôpital Privé Gériatrique Les Magnolias
  • Centre Hospitalier Bretagne Sud
  • Groupe Hospitalier Saint-Augustin
  • Hôpital Sainte-Marguerite
  • Centre Antonin Balmes
  • Hôpital Gui de Chauliac
  • Clinique Neurologique, CHU Nord
  • Centre Mémoire, Hôpital Pasteur,
  • Hôpital Broca
  • Hôpital de la Salpétrière,
  • Centre Hospitalier des Pyrénées
  • Hôpital de Jour Gériatrique
  • Hôpital Xavier-Arnozan
  • CHI Poissy-saint-germain-en-laye
  • Hôpital de Jour gériatrique
  • CHU de Rennes
  • Hôpital de Jour Gériatrique
  • CHRU de Saint-Etienne
  • Centre hospitalier Ariège Couserans
  • Hôpitaux universitaires de Strasbourg
  • Bagatelle
  • CHIC Marmande - Tonneins
  • CHU Purpan-Casselardit
  • Hôpital des Charpennes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cognitive abilities (ADAS-cog)
Functional abilities in activities of daily living (DAD scale)
Behavioural disturbance (NPI)
Apathy (Apathy Inventory)
Quality of life (Quol-AD)
Depression (MADRS)

Full Information

First Posted
March 25, 2008
Last Updated
July 31, 2013
Sponsor
University Hospital, Bordeaux
Collaborators
Caisse Nationale de Solidarité pour l'Autonomie, National Health Insurance Fund for Unemployed Workers, Direction Générale de la Santé, France, Institut National de la Santé Et de la Recherche Médicale, France, Université Victor Segalen Bordeaux 2
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1. Study Identification

Unique Protocol Identification Number
NCT00646269
Brief Title
Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease
Acronym
ETNA3
Official Title
Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Caisse Nationale de Solidarité pour l'Autonomie, National Health Insurance Fund for Unemployed Workers, Direction Générale de la Santé, France, Institut National de la Santé Et de la Recherche Médicale, France, Université Victor Segalen Bordeaux 2

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Dementia ; Alzheimer's Disease ; Non pharmacological treatments ; cognitive training ; reminiscence therapy ; efficacy assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
640 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Standard intervention protocol
Intervention Description
The control group involves a standardized medical follow-up of patients with Alzheimer's disease and a psychoeducative group program for caregivers of patients.
Intervention Type
Behavioral
Intervention Name(s)
Standard intervention protocol + Cognitive training therapy
Intervention Description
"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.
Intervention Type
Behavioral
Intervention Name(s)
Standard intervention protocol + Reminiscence therapy
Intervention Description
"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.
Intervention Type
Behavioral
Intervention Name(s)
Standard intervention protocol + "Made-to-measure" program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Cognitive abilities (ADAS-cog)
Time Frame
2 years
Title
Functional abilities in activities of daily living (DAD scale)
Time Frame
2 years
Title
Behavioural disturbance (NPI)
Time Frame
2 years
Title
Apathy (Apathy Inventory)
Time Frame
2 years
Title
Quality of life (Quol-AD)
Time Frame
2 years
Title
Depression (MADRS)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François, Dartigues, MD, PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geneviève Chêne, MD, PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CH Agen
City
Agen
ZIP/Postal Code
47923
Country
France
Facility Name
CHU Amiens Nord
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre pour Personnes Agées
City
Colmar
ZIP/Postal Code
68020
Country
France
Facility Name
Centre de Gériatrie
City
DAX
ZIP/Postal Code
40107
Country
France
Facility Name
Hôpital Dupuytren
City
Draveil
ZIP/Postal Code
92210
Country
France
Facility Name
Pôle de Gérontologie CHICAS
City
Gap
ZIP/Postal Code
05007
Country
France
Facility Name
Les Fontaines de Monjous
City
Gradignan
ZIP/Postal Code
33170
Country
France
Facility Name
CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier La Rochelle
City
La rochelle
ZIP/Postal Code
17000
Country
France
Facility Name
Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "
City
La Seyne sur Mer
ZIP/Postal Code
83500
Country
France
Facility Name
Centre Hospitalier de Libourne
City
Libourne
ZIP/Postal Code
33505
Country
France
Facility Name
CHU Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hôpital Privé Gériatrique Les Magnolias
City
Longjumeau
ZIP/Postal Code
91161
Country
France
Facility Name
Centre Hospitalier Bretagne Sud
City
Lorient
ZIP/Postal Code
56322
Country
France
Facility Name
Groupe Hospitalier Saint-Augustin
City
Malestroit
ZIP/Postal Code
56140
Country
France
Facility Name
Hôpital Sainte-Marguerite
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Centre Antonin Balmes
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Clinique Neurologique, CHU Nord
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Mémoire, Hôpital Pasteur,
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Hôpital Broca
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital de la Salpétrière,
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Centre Hospitalier des Pyrénées
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Hôpital de Jour Gériatrique
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Hôpital Xavier-Arnozan
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHI Poissy-saint-germain-en-laye
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Name
Hôpital de Jour gériatrique
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Hôpital de Jour Gériatrique
City
Saint Raphaël
ZIP/Postal Code
83700
Country
France
Facility Name
CHRU de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Centre hospitalier Ariège Couserans
City
Saint-Girons
ZIP/Postal Code
09201
Country
France
Facility Name
Hôpitaux universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Bagatelle
City
Talence
ZIP/Postal Code
33401
Country
France
Facility Name
CHIC Marmande - Tonneins
City
Tonneins
ZIP/Postal Code
47400
Country
France
Facility Name
CHU Purpan-Casselardit
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Hôpital des Charpennes
City
Villeurbanne
ZIP/Postal Code
69100
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
14583963
Citation
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.
Results Reference
background

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

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