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

University Hospital of Bordeaux

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Behavioral: Standard intervention protocol + Cognitive training therapy; Behavioral: Standard intervention protocol + Reminiscence therapy; Behavioral: Standard intervention protocol + "Made-to-measure" program; Behavioral: Standard intervention protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT00646269

2007/17

Details and patient eligibility

About

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.

Full 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

Enrollment: 640 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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640 participants in 4 patient groups

1

Active Comparator group

Treatment:

Behavioral: Standard intervention protocol

2

Experimental group

Treatment:

Behavioral: Standard intervention protocol + Cognitive training therapy

3

Experimental group

Treatment:

Behavioral: Standard intervention protocol + Reminiscence therapy

4

Experimental group

Treatment:

Behavioral: Standard intervention protocol + "Made-to-measure" program