Trial Outcomes & Findings for New Approach for Treatment of Behavioral Disorders in Alzheimer's Disease (Alzheimer's Behavioral and Cognitive Disorders) (NCT NCT02462291)
NCT ID: NCT02462291
Last Updated: 2018-10-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
163 participants
Primary outcome timeframe
PRE and POST 6 months of treatment
Results posted on
2018-10-12
Participant Flow
Participant milestones
| Measure |
Experimental Group (TR)
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
81
|
|
Overall Study
COMPLETED
|
77
|
75
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
New Approach for Treatment of Behavioral Disorders in Alzheimer's Disease (Alzheimer's Behavioral and Cognitive Disorders)
Baseline characteristics by cohort
| Measure |
Experimental Group (TR)
n=82 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=81 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76 years
STANDARD_DEVIATION 4 • n=5 Participants
|
78 years
STANDARD_DEVIATION 5 • n=7 Participants
|
77 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
82 participants
n=5 Participants
|
81 participants
n=7 Participants
|
163 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PRE and POST 6 months of treatmentThrough 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.
Outcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Evaluations of Behavioral Disorders
PRE
|
68 Scores on a scale
Standard Deviation 19
|
66 Scores on a scale
Standard Deviation 16
|
|
Evaluations of Behavioral Disorders
POST
|
36 Scores on a scale
Standard Deviation 11
|
69 Scores on a scale
Standard Deviation 16
|
PRIMARY outcome
Timeframe: PRE and POST 6 months of treatmentThrough 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.
Outcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Evaluation of Cognitive Status (Score 0-30)
PRE
|
13.2 Scores on a scale
Standard Deviation 1.7
|
13.1 Scores on a scale
Standard Deviation 1.5
|
|
Evaluation of Cognitive Status (Score 0-30)
POST
|
14.1 Scores on a scale
Standard Deviation 1.6
|
12.2 Scores on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentBody 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.
Outcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Body Composition (Kilograms of Fat Free Mass)
PRE
|
43.6 kg
Standard Deviation 5.9
|
42.8 kg
Standard Deviation 7.6
|
|
Body Composition (Kilograms of Fat Free Mass)
POST
|
43.4 kg
Standard Deviation 6.2
|
42.1 kg
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentSystolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.
Outcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Systolic Blood Pressure (mmHg)
PRE
|
132 (mmHg)
Standard Deviation 10
|
131 (mmHg)
Standard Deviation 10
|
|
Systolic Blood Pressure (mmHg)
POST
|
130 (mmHg)
Standard Deviation 9
|
132 (mmHg)
Standard Deviation 11
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentDiastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.
Outcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Diastolic Blood Pressure (mmHg)
PRE
|
81 (mmHg)
Standard Deviation 5
|
81 (mmHg)
Standard Deviation 4
|
|
Diastolic Blood Pressure (mmHg)
POST
|
78 (mmHg)
Standard Deviation 5
|
81 (mmHg)
Standard Deviation 4
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentA fasted venous blood sample will be analyzed for glucose blood levels by standard techniques.
Outcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Blood Glucose (mg/dl)
POST
|
87.42 (mg/dl)
Standard Deviation 3.76
|
88.21 (mg/dl)
Standard Deviation 3.89
|
|
Blood Glucose (mg/dl)
PRE
|
87.01 (mg/dl)
Standard Deviation 3.25
|
88.41 (mg/dl)
Standard Deviation 4.04
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentA fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques.
Outcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Blood Cholesterol HDL (mg/dl)
PRE
|
51.96 (mg/dl)
Standard Deviation 1.19
|
51.83 (mg/dl)
Standard Deviation 1.41
|
|
Blood Cholesterol HDL (mg/dl)
POST
|
51.86 (mg/dl)
Standard Deviation 1.06
|
52.29 (mg/dl)
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentA fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques.
Outcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Blood Cholesterol LDL (mg/dl)
PRE
|
98.34 (mg/dl)
Standard Deviation 3.04
|
98.41 (mg/dl)
Standard Deviation 2.68
|
|
Blood Cholesterol LDL (mg/dl)
POST
|
97.86 (mg/dl)
Standard Deviation 3.19
|
98.15 (mg/dl)
Standard Deviation 2.69
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentDaily 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.
Outcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Daily Energy Expenditure (Kcal/Day)
PRE
|
1639 (Kcal/day)
Standard Deviation 134
|
1623 (Kcal/day)
Standard Deviation 155
|
|
Daily Energy Expenditure (Kcal/Day)
POST
|
1609 (Kcal/day)
Standard Deviation 128
|
1617 (Kcal/day)
Standard Deviation 154
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentIndependence 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.
Outcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Evaluation of Activity of Daily Life
PRE
|
51.87 Scores on a scale
Standard Deviation 9.55
|
52.28 Scores on a scale
Standard Deviation 9.42
|
|
Evaluation of Activity of Daily Life
POST
|
52.49 Scores on a scale
Standard Deviation 11.41
|
51.24 Scores on a scale
Standard Deviation 9.40
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentLevels 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.
Outcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Salivary Cortisol (Nmol/l)
PRE
|
10.75 (nmol/L)
Standard Deviation 1.94
|
10.98 (nmol/L)
Standard Deviation 2.31
|
|
Salivary Cortisol (Nmol/l)
POST
|
7.82 (nmol/L)
Standard Deviation 2.30
|
10.69 (nmol/L)
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentOutcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Number of Medications
PRE
|
3.76 Number of Medications
Standard Deviation 1.22
|
3.58 Number of Medications
Standard Deviation 1.47
|
|
Number of Medications
POST
|
3.10 Number of Medications
Standard Deviation 0.95
|
3.83 Number of Medications
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentOutcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Number of Patients Treated With Quetiapine
PRE
|
41 Participants
|
37 Participants
|
|
Number of Patients Treated With Quetiapine
POST
|
35 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentOutcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Number of Patients Treated With Citalopram
PRE
|
55 Participants
|
57 Participants
|
|
Number of Patients Treated With Citalopram
POST
|
33 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentOutcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Number of Patients Treated With Donepezil
PRE
|
59 Participants
|
53 Participants
|
|
Number of Patients Treated With Donepezil
POST
|
42 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentOutcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Number of Patients Treated With Memantine
PRE
|
24 Participants
|
24 Participants
|
|
Number of Patients Treated With Memantine
POST
|
23 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: PRE and POST 6 months of treatmentOutcome measures
| Measure |
Experimental Group (TR)
n=77 Participants
A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
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.
|
Control Group (CTRL)
n=75 Participants
A group of 81 patients with AD were treated with the standard therapy.
|
|---|---|---|
|
Number of Patients Treated With Ticlopidin
PRE
|
45 Participants
|
39 Participants
|
|
Number of Patients Treated With Ticlopidin
POST
|
40 Participants
|
36 Participants
|
Adverse Events
Experimental Group (TR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group (CTRL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place