Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders

Study Overview
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Brief Summary
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The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium term effectiveness of staff education as a non-pharmacological intervention to manage apathy in older people with a diagnosis of dementia. Primary efficacy criteria: Apathy Inventory clinician score changes Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Other: Bras A (EHPAD Training and stimulation)
* Other: EHPAD Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 65 years A diagnosis of dementia according to the ICD 10 criteria MMSE score ≤ 24 Presenting the diagnostic criteria of apathy (cf page ??) An Apathy Inventory clinician total score >3 (with at least a score higher than 1 at one of the 3 dimensions; lack of initiative, lack of interest, emotional blunting) Exclusion Criteria: Patients more than 65 years MMSE score > 24

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EHPAD Training and Stimulation<br>EHPAD of the group of Training / Stimulation will benefit: after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer. of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD. | Other: Bras A (EHPAD Training and stimulation)<br>* EHPAD of the group of Training / Stimulation will benefit: after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer. of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD.<br>|
| Placebo Comparator: 2- EHPAD control<br>EHPAD of the reference group, will have their habitual functioning | Other: EHPAD Control<br>* EHPAD of the reference group, will have their habitual functioning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus. | Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes |  | 1 year |