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Completed

NCT Number: NCT02462291

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.

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Key information

Conditions

Alzheimer Disease Behavioral Disorders Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mons. Mazzali Foundation

Mantua Italy, Mantua, 46100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Person with Alzheimer's disease.

Exclusion criteria

  • Bedridden patients.

Treatment and study plan

Ecological Environmental therapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Number of Medications

    Time frame: PRE and POST 6 months of treatment

  11. Number of Patients Treated With Quetiapine

    Time frame: PRE and POST 6 months of treatment

  12. Number of Patients Treated With Citalopram

    Time frame: PRE and POST 6 months of treatment

  13. Number of Patients Treated With Donepezil

    Time frame: PRE and POST 6 months of treatment

  14. Number of Patients Treated With Memantine

    Time frame: PRE and POST 6 months of treatment

  15. Number of Patients Treated With Ticlopidin

    Time frame: PRE and POST 6 months of treatment

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Collaborators

  • Mons. Mazzali Foundation (Mantua, Italy)

Registry information

Official study title

Effectiveness of Environmental Therapy in Patients With Alzheimer's Disease

Acronym: ABCD

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 4, 2015
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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