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

U

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

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems