N/A
N=163
New Approach for Treatment of Behavioral Disorders in Alzheimer's Disease (Alzheimer's Behavioral and Cognitive Disorders)
Alzheimer Disease · Behavioral Disorders · Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02462291 ↗Enrolled (actual)
163
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Evaluations of Behavioral Disorders — 68; 66; 36; 69 Scores on a scale — p=1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ecological Environmental therapy (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Universita di Verona
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluations of Behavioral Disorders |
68; 66; 36; 69 | 1 |
| PRIMARY Evaluation of Cognitive Status (Score 0-30) |
13.2; 13.1; 14.1; 12.2 | 1 |
| SECONDARY Body Composition (Kilograms of Fat Free Mass) |
43.6; 42.8; 43.4; 42.1 | = 0.84 |
| SECONDARY Systolic Blood Pressure (mmHg) |
132; 131; 130; 132 | 0.9 |
| SECONDARY Diastolic Blood Pressure (mmHg) |
81; 81; 78; 81 | 0.83 |
| SECONDARY Blood Glucose (mg/dl) |
87.01; 88.41; 87.42; 88.21 | 0.11 |
| SECONDARY Blood Cholesterol HDL (mg/dl) |
51.96; 51.83; 51.86; 52.29 | 0.95 |
| SECONDARY Blood Cholesterol LDL (mg/dl) |
98.34; 98.41; 97.86; 98.15 | 0.84 |
| SECONDARY Daily Energy Expenditure (Kcal/Day) |
1639; 1623; 1609; 1617 | 0.94 |
| SECONDARY Evaluation of Activity of Daily Life |
51.87; 52.28; 52.49; 51.24 | 0.74 |
| SECONDARY Salivary Cortisol (Nmol/l) |
10.75; 10.98; 7.82; 10.69 | 0.9 |
| SECONDARY Number of Medications |
3.76; 3.58; 3.10; 3.83 | 0.83 |
| SECONDARY Number of Patients Treated With Quetiapine |
41; 37; 35; 37 | = 0.910 |
| SECONDARY Number of Patients Treated With Citalopram |
55; 57; 33; 53 | <0.001 sig |
| SECONDARY Number of Patients Treated With Donepezil |
59; 53; 42; 51 | 0.124 |
| SECONDARY Number of Patients Treated With Memantine |
24; 24; 23; 22 | 1 |
| SECONDARY Number of Patients Treated With Ticlopidin |
45; 39; 40; 36 | 0.789 |
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.
Eligibility Criteria
Inclusion Criteria
- Person with Alzheimer's disease.
Exclusion Criteria
- Bedridden patients.
Data sourced from ClinicalTrials.gov (NCT02462291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.