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Completed

NCT Number: NCT00646269

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CH Agen, Agen, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard intervention protocol

Behavioral

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

Behavioral

"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

Behavioral

"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

Behavioral

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 outcomes

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

    Time frame: 2 years

Secondary outcomes

  1. Cognitive abilities (ADAS-cog)

    Time frame: 2 years

  2. Functional abilities in activities of daily living (DAD scale)

    Time frame: 2 years

  3. Behavioural disturbance (NPI)

    Time frame: 2 years

  4. Apathy (Apathy Inventory)

    Time frame: 2 years

  5. Quality of life (Quol-AD)

    Time frame: 2 years

  6. Depression (MADRS)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Caisse Nationale de Solidarité pour l'Autonomie
  • Direction Générale de la Santé, France
  • Institut National de la Santé Et de la Recherche Médicale, France
  • National Health Insurance Fund for Unemployed Workers
  • Université Victor Segalen Bordeaux 2

Registry information

Acronym: ETNA3

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Mar 28, 2008
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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