Alzheimer DiseaseABCDNCT02462291
New Approach for Treatment of Behavioral Disorders in Alzheimer's Disease (Alzheimer's Behavioral and Cognitive Disorders)
A study testing Ecological Environmental therapy in people with Alzheimer Disease and Behavioral Disorders, run by Universita di Verona at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Behavioral Disorders, Cognitive Impairment
- What is being tested?
- Ecological Environmental therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Person with Alzheimer's disease.
Who cannot join
- Bedridden patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Ecological Environmental therapy
- Keywords
- Neurological Disorders, Non Pharmacological Treatment, Ecological Therapy
- Medical subject headings
- Alzheimer Disease, Mental Disorders, Cognitive Dysfunction, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Environmental therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (TR) | Experimental | 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. Receives: Other: Ecological Environmental therapy |
| Control group (CTRL) | No intervention | A group of 80 patients with AD will be treated with the standard therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: PRE and POST 6 months of treatment
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.
Measured: PRE and POST 6 months of treatment
Secondary outcomes (15)
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.
Measured: PRE and POST 6 months of treatment
Systolic Blood Pressure (mmHg)
Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.
Measured: PRE and POST 6 months of treatment
Diastolic Blood Pressure (mmHg)
Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.
Measured: PRE and POST 6 months of treatment
Blood Glucose (mg/dl)
A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques.
Measured: PRE and POST 6 months of treatment
Blood Cholesterol HDL (mg/dl)
A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques.
Measured: PRE and POST 6 months of treatment
Blood Cholesterol LDL (mg/dl)
A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques.
Measured: PRE and POST 6 months of treatment
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.
Measured: PRE and POST 6 months of treatment
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.
Measured: PRE and POST 6 months of treatment
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.
Measured: PRE and POST 6 months of treatment
Number of Medications
Measured: PRE and POST 6 months of treatment
Number of Patients Treated With Quetiapine
Measured: PRE and POST 6 months of treatment
Number of Patients Treated With Citalopram
Measured: PRE and POST 6 months of treatment
Number of Patients Treated With Donepezil
Measured: PRE and POST 6 months of treatment
Number of Patients Treated With Memantine
Measured: PRE and POST 6 months of treatment
Number of Patients Treated With Ticlopidin
Measured: PRE and POST 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Mons. Mazzali Foundation (Mantua, Italy)
- Responsible party
- Principal investigator, Massimo Venturelli, PhD, Universita di Verona
- Investigators
- Massimo Venturelli, Ph.D., Principal investigator, Universita di VeronaFederico Schena, MD; Ph.D., Study director, Universita di VeronaNicola Smania, MD, Study chair, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462291
- Sponsor's protocol ID
- 18201
- Acronym
- ABCD
- Status last verified
- Sep 2018
- First submitted
- 28 May 2015
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Calkins MP. Evidence-based long term care design. NeuroRehabilitation. 2009;25(3):145-54. doi: 10.3233/NRE-2009-0512.
PubMed 19893184Friedrich MJ. Therapeutic environmental design aims to help patients with Alzheimer disease. JAMA. 2009 Jun 17;301(23):2430. doi: 10.1001/jama.2009.809. No abstract available.
PubMed 19531775Detweiler 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.
PubMed 22707959Detweiler 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.
PubMed 18276956Smith 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.
PubMed 20150654Detweiler 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.
PubMed 19366885Heath Y. Evaluating the effect of therapeutic gardens. Am J Alzheimers Dis Other Demen. 2004 Jul-Aug;19(4):239-42. doi: 10.1177/153331750401900410.
PubMed 15359562Rodenburg M. Special facilities for patients with Alzheimer's disease. CMAJ. 1986 Feb 15;134(4):315-6. No abstract available.
PubMed 3942940Rivasseau 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.
PubMed 23207487Gonzalez 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.
PubMed 24128125York SL. Residential design and outdoor area accessibility. NeuroRehabilitation. 2009;25(3):201-8. doi: 10.3233/NRE-2009-0516.
PubMed 19893188Venturelli 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. No abstract available.
PubMed 24219216Venturelli 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.
PubMed 22984089Venturelli 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.
PubMed 21852281Venturelli 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.
PubMed 20209421
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Environmental Therapy in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02462291
- Acronym / sponsor ID
- ABCD / 18201
- Keywords
- Neurological Disorders, Non Pharmacological Treatment, Ecological Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Mons. Mazzali Foundation (Mantua, Italy)
- Study start
- Jun 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Posted 29 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (TR) | Experimental | Other: Ecological Environmental therapyA 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. |
| Control group (CTRL) | No intervention | –A group of 80 patients with AD will be treated with the standard therapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Person with Alzheimer's disease.
Key exclusion criteria (1 listed)
- Bedridden patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological Environmental therapyThe 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. | Other | Experimental group (TR) |
Primary outcome
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.
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.
15 secondary outcomes
Body Composition (Kilograms of Fat Free Mass)
Time frame: PRE and POST 6 months of treatment
Systolic Blood Pressure (mmHg)
Time frame: PRE and POST 6 months of treatment
Diastolic Blood Pressure (mmHg)
Time frame: PRE and POST 6 months of treatment
Blood Glucose (mg/dl)
Time frame: PRE and POST 6 months of treatment
Blood Cholesterol HDL (mg/dl)
Time frame: PRE and POST 6 months of treatment
Blood Cholesterol LDL (mg/dl)
Time frame: PRE and POST 6 months of treatment
Daily Energy Expenditure (Kcal/Day)
Time frame: PRE and POST 6 months of treatment
Evaluation of Activity of Daily Life
Time frame: PRE and POST 6 months of treatment
Salivary Cortisol (Nmol/l)
Time frame: PRE and POST 6 months of treatment
Number of Medications
Time frame: PRE and POST 6 months of treatment
Number of Patients Treated With Quetiapine
Time frame: PRE and POST 6 months of treatment
Number of Patients Treated With Citalopram
Time frame: PRE and POST 6 months of treatment
Number of Patients Treated With Donepezil
Time frame: PRE and POST 6 months of treatment
Number of Patients Treated With Memantine
Time frame: PRE and POST 6 months of treatment
Number of Patients Treated With Ticlopidin
Time frame: PRE and POST 6 months of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19893184Calkins MP. Evidence-based long term care design. NeuroRehabilitation. 2009;25(3):145-54. doi: 10.3233/NRE-2009-0512.
- Background: PubMed 19531775Friedrich MJ. Therapeutic environmental design aims to help patients with Alzheimer disease. JAMA. 2009 Jun 17;301(23):2430. doi: 10.1001/jama.2009.809. No abstract available.
- Background: PubMed 22707959Detweiler 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.
- Background: PubMed 18276956Detweiler 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.
- Background: PubMed 20150654Smith 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.
- Background: PubMed 19366885Detweiler 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.
- Background: PubMed 15359562Heath Y. Evaluating the effect of therapeutic gardens. Am J Alzheimers Dis Other Demen. 2004 Jul-Aug;19(4):239-42. doi: 10.1177/153331750401900410.
- Background: PubMed 3942940Rodenburg M. Special facilities for patients with Alzheimer's disease. CMAJ. 1986 Feb 15;134(4):315-6. No abstract available.
- Background: PubMed 23207487Rivasseau 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.
- Background: PubMed 24128125Gonzalez 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.
- Background: PubMed 19893188York SL. Residential design and outdoor area accessibility. NeuroRehabilitation. 2009;25(3):201-8. doi: 10.3233/NRE-2009-0516.
- Background: PubMed 24219216Venturelli 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. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Venturelli, Ph.D. principal investigator
Universita di Verona
Federico Schena, MD; Ph.D. study director
Universita di Verona
Nicola Smania, MD study chair
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological Environmental therapy in people with Alzheimer Disease and Behavioral Disorders, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluations of Behavioral Disorders (time frame: PRE and POST 6 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02462291, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.