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| Name | Class |
|---|---|
| Greek Association of Alzheimer's Disease and Related Disorders (Alzheimer Hellas) | UNKNOWN |
| RODI HELLAS SA | UNKNOWN |
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The goal of this clinical study is to learn if Pomegranate Seed Oil supplementation works to combat urinary tract infections, recurrenturinary tract infections, or pneumonia and contributes to the tapering or discontinuation of antipsychotics in palliative care patients withadvanced dementia.
The main questions it aims to answer are:
Researchers will compare Pomegranate Seed Oil to care-as-usual to see if Pomegranate Seed Oil supplementation can increase quality of care in palliative care patients with advanced dementia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomegranate Seed Oil | Experimental |
| |
| Care-as-usual | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced Dementia | Dietary Supplement | Besides Pomegranate Seed Oil Supplementation, all participants will continue to receive all ongoing care and treatments, including following the Mediterranean diet, monthly neuropsychological and behavioural assessments, physiotherapy, cognitive stimulation, occupational therapy and music therapy, without any modification |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Palliative Care Patients with Advanced Dementia with Urinary Tract Infections (UTIs) | Urinary Tract Infections were diagnosed using the revised McGeer criteria for the diagnosis of UTIs in Stone et al. (2012): Criteria from both 1 and 2
At least 10^5 cfu/mL of no more than 2 species of microorganisms in a voided urine sample At least 10^2 of any number of organisms in a specimen collected by in-and-out catheter | From enrollment to the end of treatment at 24 weeks |
| Number of Palliative Care Patients with Advanced Dementia with Reccurent Urinary Tract Infections (rUTIs) | Recurrent UTIs were classified as more than one UTI diagnosed in a single patient based on the criteria proposed in Stone et al. (2012) as described previously. | From enrollment to the end of treatment at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Palliative Care Patients with Advanced Dementia with Antipsychotic Deprescribing (Dose Reduction or Discontinuation) | From enrollment to the end of treatment at 24 weeks | |
| Number of Palliative Care Patients with Advanced Dementia Diagnosed with Pneumonia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magda Tsolaki | First Department of Neurology, Faculty of Health Sciences, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece | Study Chair |
| Ilias Maliousis | Greek Association of Alzheimer's Disease and Related Disorders (Alzheimer Hellas) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palliative Care Centre "Panagia Glykofilousa" | Thessaloniki | Central Macedonia | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22961014 | Background | Stone ND, Ashraf MS, Calder J, Crnich CJ, Crossley K, Drinka PJ, Gould CV, Juthani-Mehta M, Lautenbach E, Loeb M, Maccannell T, Malani PN, Mody L, Mylotte JM, Nicolle LE, Roghmann MC, Schweon SJ, Simor AE, Smith PW, Stevenson KB, Bradley SF; Society for Healthcare Epidemiology Long-Term Care Special Interest Group. Surveillance definitions of infections in long-term care facilities: revisiting the McGeer criteria. Infect Control Hosp Epidemiol. 2012 Oct;33(10):965-77. doi: 10.1086/667743. |
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Data Availability Statement The data supporting the findings of this study will not be publicly available due to GAADRD's internal policy to maintain the privacy of research participants and patients. However, the data will be available on reasonable request from the corresponding author.
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| Care-as-usual | Other | All participants will continue to receive all ongoing care and treatments, including a Mediterranean diet,monthly neuropsychological and behavioural assessments, physiotherapy, cognitive stimulation,occupational therapy and music therapy, without any modification |
|
As in Stone et al. (2012):
All 3 criteria must be present:
Interpretation of a chest radiograph as demonstrating pneumonia or the presence of a new infiltrate
At least 1 of the following respiratory subcriteria
At least 1 of the following criteria
| From enrollment to the end of treatment at 24 weeks |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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