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The aim of the project is to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment. This training programme focuses on the explanation/description of behavioral, cognitive and functional disorders induced by the disease, as well as principles of cognitive and psycho-social stimulation of the patients in daily life.
Context: Research showing the benefit of a combined approach including specific antidementia drugs and psycho-educational programmes for caregivers in the caring of Alzheimer's disease patients is still lacking. We venture the hypothesis that combined treatment including a specific antidementia drug for the AD patient and a psycho-educational programme for the caregivers has a larger benefit for both the patient and the caregiver on psychological, behavioural, and cognitive parameters.
Main objective: to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment.
Secondary objective: identify patterns of responders and non-responders (taking into account cognitive, psychological parameters).
Methodology: national multicentric, randomized trial, single blinded, with 2 parallel groups of 120 patients and 120 caregivers trained for a 3 month period with 3 assessments: before, just after and 3 months after the training period. Patients and caregivers are recruited (according to exclusion and inclusion criteria) and followed up in memory centers participating in the trial.
Evaluation criteria:
Primary criteria for the patient: DAD scale (Disability Assessment for Dementia).
Secondary evaluation criteria - for the patient: NPI and ADAS-Cog; for the caregiver: ZARIT scale, Questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS).
Statistical analysis by the department of biostatistics and medical computing of the Hospital Cochin will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Controlled diet | Behavioral | Controlled diet |
| |
| Self-hypnotic relaxation |
| Measure | Description | Time Frame |
|---|---|---|
| DAD scale (Disability Assessment for Dementia) | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| cardiovascular mortality | at 6 months | |
| functional status | at 4 weeks | |
| for the patient: NPI and ADAS-Cog |
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Inclusion Criteria:
Patients:
Caregivers:
Exclusion Criteria:
Patients:
Caregivers:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Sophie Rigaud, Pr, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique-Hôpitaux de Paris | Paris | Île-de-France Region | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15800450 | Background | Wenisch E, Stoker A, Bourrellis C, Pasquet C, Gauthier E, Corcos E, Banchi MT, De Rotrou J, Rigaud AS. [A global intervention program for institutionalized demented patients]. Rev Neurol (Paris). 2005 Mar;161(3):290-8. doi: 10.1016/s0035-3787(05)85035-0. French. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Behavioral |
Self-hypnotic relaxation |
|
| during the study |
| for the caregiver: ZARIT scale, questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS) | during the study |
| all cause mortality | at one year |
| score on a depression rating scale | at 6 weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |