Antipsychotics Discontinuation, Antipsychotics Tapering, Urinary Tract Infection, Recurrent, Urinary Tract Infections (UTIs)
Conditions
Keywords
Pomegranate Seed Oil, Mediterranean Diet, Palliative Care, Advanced Dementia, Patient Safety, Urinary Tract Infections, Antipsychotics, Randomized Clinical Trial
Brief summary
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: * Does Pomegranate Seed Oil supplementation reduce the likelihood of developing a urinary tract infection? * Does Pomegranate Seed Oil supplementation prevent UTI reinfection? * Does Pomegranate Seed Oil supplementation reduce the likelihood of pneumonia? * Does Pomegranate Seed Oil supplementation contribute to the tapering or discontinuation of antipsychotics? 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.
Interventions
DIETARY_SUPPLEMENTPomegranate Seed Oil Supplementation in Palliative Care Patients with Advanced Dementia
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
OTHERCare-as-usual
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
Sponsors
Panhellenic Federation of Alzheimer's Disease and Related Disorders
Greek Association of Alzheimer's Disease and Related Disorders (Alzheimer Hellas)
RODI HELLAS SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 65+ * Dementia diagnosis (major neurocognitive disorder) according to the criteria Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) or the International Statistical Classification of Diseases and Related Health Problems (ICD-11) * Participants classified as Stage 7, Profound Cognitive Decline on the Global Deterioration Scale, corresponding to advanced dementia * AD related biomarkers in CSF * Caregiver consent for study participation
Exclusion criteria
* History of allergy to the supplement or any of its components * Prior diagnosis of Schizophrenia Spectrum and Other Psychotic Disorders according to the criteria Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) or the International Statistical Classification of Diseases and Related Health Problems (ICD-11) * Participants having medical history of recurring urinary tract infections * Participants having medical history of renal or liver failure * Participants concurrently participating in other clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Palliative Care Patients with Advanced Dementia with Urinary Tract Infections (UTIs) | From enrollment to the end of treatment at 24 weeks | 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 1. At least 1 of the following: Acute dysuria or acute pain, swelling, or tenderness of the testes, epididymis, or prostate OR Fever or leukocytosis and at least 1 of the following localizing urinary tract sub-criteria: Acute costovertebral angle pain or tenderness Suprapubic pain Gross hematuria New or marked increase in incontinence New or marked increase in urgency New or marked increase in frequency In the absence of fever or leukocytosis, then 2 or more of the following: Suprapubic pain Gross hematuria New or marked increase in incontinence New or marked increase in urgency New or marked increase in frequency 2. One of the following: 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 |
| Number of Palliative Care Patients with Advanced Dementia with Reccurent Urinary Tract Infections (rUTIs) | From enrollment to the end of treatment at 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From enrollment to the end of treatment at 24 weeks | As in Stone et al. (2012): All 3 criteria must be present: 1. Interpretation of a chest radiograph as demonstrating pneumonia or the presence of a new infiltrate 2. At least 1 of the following respiratory subcriteria 1. New or increased cough 2. New or increased sputum production 3. O2 saturation \<94% on room air or a reduction in O2 saturation of \>3% from baseline 4. New or changed lung examination abnormalities 5. Pleuritic chest pain 6. Respiratory rate of ≥25 breaths/min 3. At least 1 of the following criteria 1. Fever 2. Leukocytosis 3. Acute change in mental status from baseline and either disorganized thinking or altered level of consciousness 4. Acute functional decline |
Countries
Greece
Contacts
STUDY_CHAIRMagda Tsolaki
First Department of Neurology, Faculty of Health Sciences, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece
PRINCIPAL_INVESTIGATORIlias Maliousis
Greek Association of Alzheimer's Disease and Related Disorders (Alzheimer Hellas)
Outcome results
None listed