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

Alzheimer Disease Clinical Trial

— ABCD  

Official title:

Effectiveness of Environmental Therapy in Patients With Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462291
• Other study ID #: 18201
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2018
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Person with Alzheimer's disease.

Exclusion Criteria:

• Bedridden patients.

Related Conditions & MeSH terms

• Alzheimer Disease
• Behavioral Disorders
• Cognitive Dysfunction
• Cognitive Impairment
• Mental Disorders
• Problem Behavior

Intervention

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.

Locations

Country	Name	City	State
Italy	Mons. Mazzali Foundation	Mantua Italy	Mantua

Sponsors (2)

Lead Sponsor	Collaborator
Universita di Verona	Mons. Mazzali Foundation (Mantua, Italy)

Country where clinical trial is conducted

Italy, 

References & Publications (15)

Calkins MP. Evidence-based long term care design. NeuroRehabilitation. 2009;25(3):145-54. doi: 10.3233/NRE-2009-0512. Review. — View Citation

Detweiler MB, Murphy PF, Kim KY, Myers LC, Ashai A. Scheduled medications and falls in dementia patients utilizing a wander garden. Am J Alzheimers Dis Other Demen. 2009 Aug-Sep;24(4):322-32. doi: 10.1177/1533317509334036. Epub 2009 Apr 14. — View Citation

Detweiler MB, Murphy PF, Myers LC, Kim KY. Does a wander garden influence inappropriate behaviors in dementia residents? Am J Alzheimers Dis Other Demen. 2008 Feb-Mar;23(1):31-45. doi: 10.1177/1533317507309799. — View Citation

Detweiler MB, Sharma T, Detweiler JG, Murphy PF, Lane S, Carman J, Chudhary AS, Halling MH, Kim KY. What is the evidence to support the use of therapeutic gardens for the elderly? Psychiatry Investig. 2012 Jun;9(2):100-10. doi: 10.4306/pi.2012.9.2.100. Epub 2012 May 22. — View Citation

Friedrich MJ. Therapeutic environmental design aims to help patients with Alzheimer disease. JAMA. 2009 Jun 17;301(23):2430. doi: 10.1001/jama.2009.809. — View Citation

Gonzalez MT, Kirkevold M. Benefits of sensory garden and horticultural activities in dementia care: a modified scoping review. J Clin Nurs. 2014 Oct;23(19-20):2698-715. doi: 10.1111/jocn.12388. Epub 2013 Oct 15. Review. — View Citation

Heath Y. Evaluating the effect of therapeutic gardens. Am J Alzheimers Dis Other Demen. 2004 Jul-Aug;19(4):239-42. — View Citation

Rivasseau Jonveaux T, Batt M, Fescharek R, Benetos A, Trognon A, Bah Chuzeville S, Pop A, Jacob C, Yzoard M, Demarche L, Soulon L, Malerba G, Bouvel B. Healing gardens and cognitive behavioral units in the management of Alzheimer's disease patients: the Nancy experience. J Alzheimers Dis. 2013;34(1):325-38. doi: 10.3233/JAD-121657. — View Citation

Rodenburg M. Special facilities for patients with Alzheimer's disease. CMAJ. 1986 Feb 15;134(4):315-6. — View Citation

Smith R, Mathews RM, Gresham M. Pre- and postoccupancy evaluation of new dementia care cottages. Am J Alzheimers Dis Other Demen. 2010 May;25(3):265-75. doi: 10.1177/1533317509357735. Epub 2010 Feb 11. — View Citation

Venturelli M, Lanza M, Muti E, Schena F. Positive effects of physical training in activity of daily living-dependent older adults. Exp Aging Res. 2010 Apr;36(2):190-205. doi: 10.1080/03610731003613771. — View Citation

Venturelli M, Magalini A, Scarsini R, Schena F. From Alzheimer's disease retrogenesis: a new care strategy for patients with advanced dementia. Am J Alzheimers Dis Other Demen. 2012 Nov;27(7):483-9. doi: 10.1177/1533317512459794. Epub 2012 Sep 13. — View Citation

Venturelli M, Scarsini R, Muti E, Salvagno GL, Schena F. Sundowning syndrome and hypothalamic-pituitary-adrenal axis dysregulation in individuals with Alzheimer's disease: is there an association? J Am Geriatr Soc. 2013 Nov;61(11):2055-6. doi: 10.1111/jgs.12491. — View Citation

Venturelli M, Scarsini R, Schena F. Six-month walking program changes cognitive and ADL performance in patients with Alzheimer. Am J Alzheimers Dis Other Demen. 2011 Aug;26(5):381-8. doi: 10.1177/1533317511418956. Epub 2011 Aug 17. — View Citation

York SL. Residential design and outdoor area accessibility. NeuroRehabilitation. 2009;25(3):201-8. doi: 10.3233/NRE-2009-0516. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluations of Behavioral Disorders	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
Primary	Evaluation of Cognitive Status (Score 0-30)	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	Body Composition (Kilograms of Fat Free Mass)	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
Secondary	Systolic Blood Pressure (mmHg)	Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.	PRE and POST 6 months of treatment
Secondary	Diastolic Blood Pressure (mmHg)	Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.	PRE and POST 6 months of treatment
Secondary	Blood Glucose (mg/dl)	A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques.	PRE and POST 6 months of treatment
Secondary	Blood Cholesterol HDL (mg/dl)	A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques.	PRE and POST 6 months of treatment
Secondary	Blood Cholesterol LDL (mg/dl)	A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques.	PRE and POST 6 months of treatment
Secondary	Daily Energy Expenditure (Kcal/Day)	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
Secondary	Evaluation of Activity of Daily Life	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
Secondary	Salivary Cortisol (Nmol/l)	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
Secondary	Number of Medications		PRE and POST 6 months of treatment
Secondary	Number of Patients Treated With Quetiapine		PRE and POST 6 months of treatment
Secondary	Number of Patients Treated With Citalopram		PRE and POST 6 months of treatment
Secondary	Number of Patients Treated With Donepezil		PRE and POST 6 months of treatment
Secondary	Number of Patients Treated With Memantine		PRE and POST 6 months of treatment
Secondary	Number of Patients Treated With Ticlopidin		PRE and POST 6 months of treatment