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

September 14, 2018 updated by: Massimo Venturelli, PhD, Universita di Verona

Effectiveness of Environmental Therapy in Patients With Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Mantua
      • Mantua Italy, Mantua, Italy, 46100
        • Mons. Mazzali Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Person with Alzheimer's disease.

Exclusion Criteria:

  • Bedridden patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group (TR)
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
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.
No Intervention: Control group (CTRL)
A group of 80 patients with AD will be treated with the standard therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluations of Behavioral Disorders
Time Frame: 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.
PRE and POST 6 months of treatment
Evaluation of Cognitive Status (Score 0-30)
Time Frame: 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.
PRE and POST 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition (Kilograms of Fat Free Mass)
Time Frame: 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.
PRE and POST 6 months of treatment
Systolic Blood Pressure (mmHg)
Time Frame: PRE and POST 6 months of treatment
Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.
PRE and POST 6 months of treatment
Diastolic Blood Pressure (mmHg)
Time Frame: PRE and POST 6 months of treatment
Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.
PRE and POST 6 months of treatment
Blood Glucose (mg/dl)
Time Frame: PRE and POST 6 months of treatment
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)
Time Frame: PRE and POST 6 months of treatment
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)
Time Frame: PRE and POST 6 months of treatment
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)
Time Frame: 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.
PRE and POST 6 months of treatment
Evaluation of Activity of Daily Life
Time Frame: 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.
PRE and POST 6 months of treatment
Salivary Cortisol (Nmol/l)
Time Frame: 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.
PRE and POST 6 months of treatment
Number of Medications
Time Frame: PRE and POST 6 months of treatment
PRE and POST 6 months of treatment
Number of Patients Treated With Quetiapine
Time Frame: PRE and POST 6 months of treatment
PRE and POST 6 months of treatment
Number of Patients Treated With Citalopram
Time Frame: PRE and POST 6 months of treatment
PRE and POST 6 months of treatment
Number of Patients Treated With Donepezil
Time Frame: PRE and POST 6 months of treatment
PRE and POST 6 months of treatment
Number of Patients Treated With Memantine
Time Frame: PRE and POST 6 months of treatment
PRE and POST 6 months of treatment
Number of Patients Treated With Ticlopidin
Time Frame: PRE and POST 6 months of treatment
PRE and POST 6 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Collaborators

Mons. Mazzali Foundation (Mantua, Italy)

Investigators

  • Principal Investigator: Massimo Venturelli, Ph.D., Universita di Verona
  • Study Director: Federico Schena, MD; Ph.D., Universita di Verona
  • Study Chair: Nicola Smania, MD, Universita di Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

September 14, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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