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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

March 25, 2008
July 31, 2013
March 2008
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00646269 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease
Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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.
  • 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.
  • 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.
  • 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.
  • Active Comparator: 1
    Intervention: Behavioral: Standard intervention protocol
  • Experimental: 2
    Intervention: Behavioral: Standard intervention protocol + Cognitive training therapy
  • Experimental: 3
    Intervention: Behavioral: Standard intervention protocol + Reminiscence therapy
  • Experimental: 4
    Intervention: Behavioral: Standard intervention protocol + "Made-to-measure" program
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
640
December 2012
December 2010   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00646269
2007/17
Yes
University Hospital, Bordeaux
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
Principal Investigator: Jean-François , Dartigues, MD, PhD University Hospital of Bordeaux
Study Chair: Geneviève Chêne, MD, PhD University Hospital of Bordeaux
University Hospital, Bordeaux
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP