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

Not Applicable

Completed

Conditions: Behavioral Disorders
Alzheimer Disease
Cognitive Impairment

Interventions: Other: Ecological Environmental therapy

Registration Number: NCT02462291

Lead Sponsor: Universita di Verona

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 163

Inclusion Criteria

Person with Alzheimer's disease.

Exclusion Criteria

Bedridden patients.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (TR)	Ecological Environmental 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.

Primary Outcome Measures

Name	Time	Method
Evaluations of Behavioral Disorders	PRE and POST 6 months of treatment	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.
Evaluation of Cognitive Status (Score 0-30)	PRE and POST 6 months of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Treated With Donepezil	PRE and POST 6 months of treatment
Body Composition (Kilograms of Fat Free Mass)	PRE and POST 6 months of treatment	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 (mmHg)	PRE and POST 6 months of treatment	Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.
Diastolic Blood Pressure (mmHg)	PRE and POST 6 months of treatment	Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.
Blood Glucose (mg/dl)	PRE and POST 6 months of treatment	A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques.
Blood Cholesterol HDL (mg/dl)	PRE and POST 6 months of treatment	A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques.
Blood Cholesterol LDL (mg/dl)	PRE and POST 6 months of treatment	A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques.
Daily Energy Expenditure (Kcal/Day)	PRE and POST 6 months of treatment	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.
Salivary Cortisol (Nmol/l)	PRE and POST 6 months of treatment	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.
Number of Medications	PRE and POST 6 months of treatment
Number of Patients Treated With Quetiapine	PRE and POST 6 months of treatment
Evaluation of Activity of Daily Life	PRE and POST 6 months of treatment	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.
Number of Patients Treated With Memantine	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 Ticlopidin	PRE and POST 6 months of treatment