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

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

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.

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.

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.

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.

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.

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.

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.

Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.

Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.

A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques.

A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques.

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.

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.

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.

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