Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease
NCT ID: NCT00646269
Last Updated: 2013-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
640 participants
INTERVENTIONAL
2008-03-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
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.
2
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.
3
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.
4
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Patients over 50 years of age
* Patients with social security affiliation
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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Caisse Nationale de Solidarité pour l'Autonomie
OTHER
National Health Insurance Fund for Unemployed Workers
OTHER
Direction Générale de la Santé, France
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Université Victor Segalen Bordeaux 2
OTHER
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Jean-François, Dartigues, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Geneviève Chêne, MD, PhD
Role: STUDY_CHAIR
University Hospital, Bordeaux
Locations
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CH Agen
Agen, , France
CHU Amiens Nord
Amiens, , France
Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux
Bordeaux, , France
Hôpital Pellegrin
Bordeaux, , France
CHU Côte de Nacre
Caen, , France
Centre pour Personnes Agées
Colmar, , France
Centre de Gériatrie
Dax, , France
Hôpital Dupuytren
Draveil, , France
Pôle de Gérontologie CHICAS
Gap, , France
Les Fontaines de Monjous
Gradignan, , France
CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble
Grenoble, , France
Centre Hospitalier La Rochelle
La Rochelle, , France
Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "
La Seyne-sur-Mer, , France
Centre Hospitalier de Libourne
Libourne, , France
CHU Limoges
Limoges, , France
Hôpital Privé Gériatrique Les Magnolias
Longjumeau, , France
Centre Hospitalier Bretagne Sud
Lorient, , France
Groupe Hospitalier Saint-Augustin
Malestroit, , France
Hôpital Sainte-Marguerite
Marseille, , France
Centre Antonin Balmes
Montpellier, , France
Hôpital Gui de Chauliac
Montpellier, , France
Clinique Neurologique, CHU Nord
Nantes, , France
Centre Mémoire, Hôpital Pasteur,
Nice, , France
Hôpital Broca
Paris, , France
Hôpital de la Salpétrière,
Paris, , France
Centre Hospitalier des Pyrénées
Pau, , France
Hôpital de Jour Gériatrique
Pau, , France
Hôpital Xavier-Arnozan
Pessac, , France
CHI Poissy-saint-germain-en-laye
Poissy, , France
Hôpital de Jour gériatrique
Poitiers, , France
CHU de Rennes
Rennes, , France
CHRU de Saint-Etienne
Saint-Etienne, , France
Centre hospitalier Ariège Couserans
Saint-Girons, , France
Hôpital de Jour Gériatrique
Saint-Raphaël, , France
Hôpitaux universitaires de Strasbourg
Strasbourg, , France
Bagatelle
Talence, , France
CHIC Marmande - Tonneins
Tonneins, , France
CHU Purpan-Casselardit
Toulouse, , France
Hôpital des Charpennes
Villeurbanne, , France
Countries
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References
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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. doi: 10.1002/14651858.CD003260.
Other Identifiers
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2007/17
Identifier Type: -
Identifier Source: org_study_id
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