Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease (ETNA3)
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital, Bordeaux
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 18, 2012
Last verified: July 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 25, 2008 | ||||||||
| Last Updated Date | July 18, 2012 | ||||||||
| Start Date ICMJE | March 2008 | ||||||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00646269 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease | ||||||||
| Official Title ICMJE | Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease | ||||||||
| Brief 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. |
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| Detailed 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 |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Alzheimer's Disease | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 800 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00646269 | ||||||||
| Other Study ID Numbers ICMJE | 2007/17 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University Hospital, Bordeaux | ||||||||
| Study Sponsor ICMJE | University Hospital, Bordeaux | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital, Bordeaux | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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