CompletedNot Applicable

Effects of Pomegranate Seed Oil Supplementation in Patients With Advanced Dementia

Greece18 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Palliative Care Patients with Advanced Dementia with Urinary Tract Infections (UTIs)

Timeframe: From enrollment to the end of treatment at 24 weeks

Number of Palliative Care Patients with Advanced Dementia with Reccurent Urinary Tract Infections (rUTIs)

Timeframe: From enrollment to the end of treatment at 24 weeks

Trial details

NCT IDNCT07432763

SponsorPanhellenic Federation of Alzheimer's Disease and Related Disorders

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Urinary Tract Infections (UTIs) trials

Plain-language summary

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Palliative Care Patients with Advanced Dementia with Urinary Tract Infections (UTIs)

Timeframe: From enrollment to the end of treatment at 24 weeks

Number of Palliative Care Patients with Advanced Dementia with Reccurent Urinary Tract Infections (rUTIs)

Timeframe: From enrollment to the end of treatment at 24 weeks