Clinical trial NCT00646269: Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease
Official title: Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Dementia ; Alzheimer's Disease ; Non pharmacological treatments ; cognitive training ; reminiscence therapy ; efficacy assessment
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Caisse Nationale de Solidarité pour l'Autonomie
name: National Health Insurance Fund for Unemployed Workers
name: Direction Générale de la Santé, France
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Université Victor Segalen Bordeaux 2
First posted: 2008-03-28
Enrollment: 640
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower)
timeFrame: 2 years
Secondary outcomes:
measure: Cognitive abilities (ADAS-cog)
timeFrame: 2 years
measure: Functional abilities in activities of daily living (DAD scale)
timeFrame: 2 years
measure: Behavioural disturbance (NPI)
timeFrame: 2 years
measure: Apathy (Apathy Inventory)
timeFrame: 2 years
measure: Quality of life (Quol-AD)
timeFrame: 2 years
measure: Depression (MADRS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Agen
country: France
facility: CH Agen
city: Amiens
country: France
facility: CHU Amiens Nord
city: Bordeaux
country: France
facility: Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Caen
country: France
facility: CHU Côte de Nacre
city: Colmar
country: France
facility: Centre pour Personnes Agées
city: DAX
country: France
facility: Centre de Gériatrie
city: Draveil
country: France
facility: Hôpital Dupuytren
city: Gap
country: France
facility: Pôle de Gérontologie CHICAS
city: Gradignan
country: France
facility: Les Fontaines de Monjous
city: Grenoble
country: France
facility: CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble
city: La rochelle
country: France
facility: Centre Hospitalier La Rochelle
city: La Seyne sur Mer
country: France
facility: Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "
city: Libourne
country: France
facility: Centre Hospitalier de Libourne
city: Limoges
country: France
facility: CHU Limoges
city: Longjumeau
country: France
facility: Hôpital Privé Gériatrique Les Magnolias
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud
city: Malestroit
country: France
facility: Groupe Hospitalier Saint-Augustin
city: Marseille
country: France
facility: Hôpital Sainte-Marguerite
city: Montpellier
country: France
facility: Centre Antonin Balmes
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Nantes
country: France
facility: Clinique Neurologique, CHU Nord
city: Nice
country: France
facility: Centre Mémoire, Hôpital Pasteur,
city: Paris
country: France
facility: Hôpital Broca
city: Paris
country: France
facility: Hôpital de la Salpétrière,
city: Pau
country: France
facility: Centre Hospitalier des Pyrénées
city: Pau
country: France
facility: Hôpital de Jour Gériatrique
city: Pessac
country: France
facility: Hôpital Xavier-Arnozan
city: Poissy
country: France
facility: CHI Poissy-saint-germain-en-laye
city: Poitiers
country: France
facility: Hôpital de Jour gériatrique
city: Rennes
country: France
facility: CHU de Rennes
city: Saint Raphaël
country: France
facility: Hôpital de Jour Gériatrique
city: Saint-Etienne
country: France
facility: CHRU de Saint-Etienne
city: Saint-Girons
country: France
facility: Centre hospitalier Ariège Couserans
city: Strasbourg
country: France
facility: Hôpitaux universitaires de Strasbourg
city: Talence
country: France
facility: Bagatelle
city: Tonneins
country: France
facility: CHIC Marmande - Tonneins
city: Toulouse
country: France
facility: CHU Purpan-Casselardit
city: Villeurbanne
country: France
facility: Hôpital des Charpennes
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-François, Dartigues, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Geneviève Chêne, MD, PhD
role: STUDY_CHAIR
References:
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.