New Approach for Treatment of Behavioral Disorders in Alzheimer's Disease (Alzheimer's Behavioral and Cognitive Disorders)

Study Overview
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Brief Summary
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Alzheimer's disease (AD) is the most frequent form of dementia, causing high level of disability with elevated social costs. Alternative solutions to the standard pharmacological therapies have been studied in order to reduce the use of medications that frequently generates side effects and worsen patients' quality of life. A recent alternative treatment for AD is the Environmental Ecological Therapy (EET) that, with the use of therapeutic gardens, seems to reduce behavioral disorders (BD). However, the effectiveness of this approach is still mater of debate. Therefore, the aim of this trial will be to analyze the effects of EET, in people with severe AD.

Detailed Description
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Since Homo sapiens evolved in a natural environment, an intrinsic physiologic and psychological positive reaction to nature has been developed. Accordingly, emerging literature highlights the positive effect of therapeutic gardens, as environmental ecological therapy (EET) on the reduction of behavioral disorders (BD) and the preservation of cognitive functions in patients with Alzheimer's disease (AD). Despite these promising preliminary studies, limited data are available on the effectiveness of EET in individuals with advanced AD. Therefore, the aim of the current trial will be to evaluate the effectiveness of EET on AD symptoms in patients with advanced AD. Participants with advanced AD will be selected from among residents of the Alzheimer's care units of the Mons. Mazzali Foundation (Mantua, Italy). Selected participants will be randomly assigned to a treatment group (TR), or to a control group (CTRL). Participants assigned to TR group will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months. Individuals assigned to the CTRL group will be treated with a standard therapy.

Official Title
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Effectiveness of Environmental Therapy in Patients With Alzheimer's Disease

Conditions
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Alzheimer Disease, Behavioral Disorders, Cognitive Impairment

Intervention / Treatment
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* Other: Ecological Environmental therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Person with Alzheimer's disease. Exclusion Criteria: Bedridden patients.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (TR)<br>A group of 80 patients with AD will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months. | Other: Ecological Environmental therapy<br>* The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD.<br>|
| No Intervention: Control group (CTRL)<br>A group of 80 patients with AD will be treated with the standard therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluations of Behavioral Disorders | Through the use of Neuropsychiatric Inventory (NPI), the investigators assessed the frequency and the severity of the behavioral disorders. The total scale range of the NPI is 0-144, and higher values represent worse outcome. | PRE and POST 6 months of treatment | 
| Evaluation of Cognitive Status (Score 0-30) | Through the use of Mini Mental State Examination (MMSE) the investigators estimated the severity and progression of cognitive impairment. MMSE is a questionnaire that examines cognitive functions including registration, attention, calculation, recall, language, ability to follow simple commands and orientation. The scale range of the MMSE tests is 0-30, and higher values represent a better outcome. | PRE and POST 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition (Kilograms of Fat Free Mass) | Body mass and skin-fold measurements were measured three times a day by the same experienced operator. The average value of the three measurements was calculated. Kilograms of fat free mass was estimated using a validated equation. | PRE and POST 6 months of treatment | 
| Systolic Blood Pressure (mmHg) | Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique. | PRE and POST 6 months of treatment | 
| Diastolic Blood Pressure (mmHg) | Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique. | PRE and POST 6 months of treatment | 
| Blood Glucose (mg/dl) | A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques. | PRE and POST 6 months of treatment | 
| Blood Cholesterol HDL (mg/dl) | A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques. | PRE and POST 6 months of treatment | 
| Blood Cholesterol LDL (mg/dl) | A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques. | PRE and POST 6 months of treatment | 
| Daily Energy Expenditure (Kcal/Day) | Daily energy expenditure was measured with an Actiheart device (CamNtech, Cambridge, UK) allowing heart rate and acceleration data to be simultaneously recorded for 24 h/day for 7 consecutive days. | PRE and POST 6 months of treatment | 
| Evaluation of Activity of Daily Life | Independence and level of activities of daily life (ADL) were evaluated with the Barthel index. Levels of ADL was measured by observing each resident's daily activities (eating, bathing, grooming, dressing, transfers from bed to chair, mobility on level planes, stairs, and getting on/off the toilet). The total score of the Barthel index is 0-100, and higher values represent a better outcome. | PRE and POST 6 months of treatment | 
| Salivary Cortisol (Nmol/l) | Levels of cortisol was measured via saliva samples using plain Sarstedt Salivette collection devices (Nümbrecht, Germany). Samples will be collected at 6.30 AM, 11.30 AM, and 6.30 PM. Immediately after collecting the saliva samples, were centrifuged for 2 min at 1,000 rpm. Purified saliva was stored in a freezer at -20 °C, and subsequently analyzed. Cortisol levels was determined by a time-resolved immunoassay with fluorometric detection. | PRE and POST 6 months of treatment | 
| Number of Medications |  | PRE and POST 6 months of treatment | 
| Number of Patients Treated With Quetiapine |  | PRE and POST 6 months of treatment | 
| Number of Patients Treated With Citalopram |  | PRE and POST 6 months of treatment | 
| Number of Patients Treated With Donepezil |  | PRE and POST 6 months of treatment | 
| Number of Patients Treated With Memantine |  | PRE and POST 6 months of treatment | 
| Number of Patients Treated With Ticlopidin |  | PRE and POST 6 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurological Disorders, Non Pharmacological Treatment, Ecological Therapy