Clinical trial NCT02462291: New Approach for Treatment of Behavioral Disorders in Alzheimer's Disease (Alzheimer's Behavioral and Cognitive Disorders)
Official title: Effectiveness of Environmental Therapy in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Behavioral Disorders
Cognitive Impairment
Keywords: Neurological Disorders
Non Pharmacological Treatment
Ecological Therapy
Lead sponsor: Universita di Verona
Sponsor class: OTHER
Collaborators: name: Mons. Mazzali Foundation (Mantua, Italy)
First posted: 2015-06-04
Enrollment: 163
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Person with Alzheimer's disease.

Exclusion Criteria:

* Bedridden patients.

Primary outcomes:
measure: Evaluations of Behavioral Disorders
timeFrame: PRE and POST 6 months of treatment
measure: Evaluation of Cognitive Status (Score 0-30)
timeFrame: PRE and POST 6 months of treatment
Secondary outcomes:
measure: Body Composition (Kilograms of Fat Free Mass)
timeFrame: PRE and POST 6 months of treatment
measure: Systolic Blood Pressure (mmHg)
timeFrame: PRE and POST 6 months of treatment
measure: Diastolic Blood Pressure (mmHg)
timeFrame: PRE and POST 6 months of treatment
measure: Blood Glucose (mg/dl)
timeFrame: PRE and POST 6 months of treatment
measure: Blood Cholesterol HDL (mg/dl)
timeFrame: PRE and POST 6 months of treatment
measure: Blood Cholesterol LDL (mg/dl)
timeFrame: PRE and POST 6 months of treatment
measure: Daily Energy Expenditure (Kcal/Day)
timeFrame: PRE and POST 6 months of treatment
measure: Evaluation of Activity of Daily Life
timeFrame: PRE and POST 6 months of treatment
measure: Salivary Cortisol (Nmol/l)
timeFrame: PRE and POST 6 months of treatment
measure: Number of Medications
timeFrame: PRE and POST 6 months of treatment
measure: Number of Patients Treated With Quetiapine
timeFrame: PRE and POST 6 months of treatment
measure: Number of Patients Treated With Citalopram
timeFrame: PRE and POST 6 months of treatment
measure: Number of Patients Treated With Donepezil
timeFrame: PRE and POST 6 months of treatment
measure: Number of Patients Treated With Memantine
timeFrame: PRE and POST 6 months of treatment
measure: Number of Patients Treated With Ticlopidin
timeFrame: PRE and POST 6 months of treatment
Other outcomes:
Locations:
city: Mantua Italy
country: Italy
facility: Mons. Mazzali Foundation
state: Mantua
Study officials:
affiliation: Universita di Verona
name: Massimo Venturelli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Federico Schena, MD; Ph.D.
role: STUDY_DIRECTOR
affiliation: Universita di Verona
name: Nicola Smania, MD
role: STUDY_CHAIR
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