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

Alzheimer's Disease Clinical Trial

— ETNA3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646269
• Other study ID #: 2007/17
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2008
• Last updated: July 31, 2013
• Start date: March 2008
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	CH Agen	Agen
France	CHU Amiens Nord	Amiens
France	Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux	Bordeaux
France	Hôpital Pellegrin	Bordeaux
France	CHU Côte de Nacre	Caen
France	Centre pour Personnes Agées	Colmar
France	Centre de Gériatrie	DAX
France	Hôpital Dupuytren	Draveil
France	Pôle de Gérontologie CHICAS	Gap
France	Les Fontaines de Monjous	Gradignan
France	CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble	Grenoble
France	Centre Hospitalier La Rochelle	La rochelle
France	Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "	La Seyne sur Mer
France	Centre Hospitalier de Libourne	Libourne
France	CHU Limoges	Limoges
France	Hôpital Privé Gériatrique Les Magnolias	Longjumeau
France	Centre Hospitalier Bretagne Sud	Lorient
France	Groupe Hospitalier Saint-Augustin	Malestroit
France	Hôpital Sainte-Marguerite	Marseille
France	Centre Antonin Balmes	Montpellier
France	Hôpital Gui de Chauliac	Montpellier
France	Clinique Neurologique, CHU Nord	Nantes
France	Centre Mémoire, Hôpital Pasteur,	Nice
France	Hôpital Broca	Paris
France	Hôpital de la Salpétrière,	Paris
France	Centre Hospitalier des Pyrénées	Pau
France	Hôpital de Jour Gériatrique	Pau
France	Hôpital Xavier-Arnozan	Pessac
France	CHI Poissy-saint-germain-en-laye	Poissy
France	Hôpital de Jour gériatrique	Poitiers
France	CHU de Rennes	Rennes
France	Hôpital de Jour Gériatrique	Saint Raphaël
France	CHRU de Saint-Etienne	Saint-Etienne
France	Centre hospitalier Ariège Couserans	Saint-Girons
France	Hôpitaux universitaires de Strasbourg	Strasbourg
France	Bagatelle	Talence
France	CHIC Marmande - Tonneins	Tonneins
France	CHU Purpan-Casselardit	Toulouse
France	Hôpital des Charpennes	Villeurbanne

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Caisse Nationale d'Assurance Maladie des Travailleurs Non Salariés, Caisse Nationale de Solidarité pour l'Autonomie, Direction Générale de la Santé, France, Institut National de la Santé Et de la Recherche Médicale, France, Université Victor Segalen Bordeaux 2

Country where clinical trial is conducted

France, 

References & 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. Review. Update in: Cochrane Database Syst Rev. 2013;6:CD003260. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of progression to the severe stage of Alzheimer's disease (MMSE score of 15 or lower)		2 years	No
Secondary	Cognitive abilities (ADAS-cog)		2 years	No
Secondary	Functional abilities in activities of daily living (DAD scale)		2 years	No
Secondary	Behavioural disturbance (NPI)		2 years	No
Secondary	Apathy (Apathy Inventory)		2 years	No
Secondary	Quality of life (Quol-AD)		2 years	No
Secondary	Depression (MADRS)		2 years	No