Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease training programme, educational programme caregivers carers dementia treatment, Dementia Cognitive disorder
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALControlled diet
Controlled diet
BEHAVIORALSelf-hypnotic relaxation
Self-hypnotic relaxation
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients: * AD outpatients * Stable pharmacological treatment * Mini-Mental State Examination (MMSE) \[10 -28\] * Age \[60-90\] * Informed consent Caregivers: * Reliability * Motivation * Psychological disorder related to patient's disease * Need for information or help * Informed consent
Exclusion criteria
Patients: * Other dementia * Severe general disease * No reliable caregiver Caregivers: * Physical or mental disease incompatible with patient's management * Impossibility to participate in the educational program * Absence of anxiety-depression * Psychotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAD scale (Disability Assessment for Dementia) | at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| functional status | at 4 weeks |
| for the patient: NPI and ADAS-Cog | during the study |
| cardiovascular mortality | at 6 months |
| all cause mortality | at one year |
| score on a depression rating scale | at 6 weeks |
| for the caregiver: ZARIT scale, questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS) | during the study |
Countries
France
Outcome results
None listed