CompletedNot Applicable

Drug Burden Index is Associated With Malnutrition in Community-dwelling Dementia Patients

Turkey (Türkiye)415 participantsStarted 2023-05-20

Plain-language summary

Malnutrition leads to poor clinical outcomes in dementia patients. The investigator aimed to examine the association between drug burden index (DBI) and anticholinergic burden (ACB) scores with nutrition status in community-dwelling older adults with dementia, considering that drugs may contribute malnutrition. A total of 415 outpatients with dementia, evaluated by Mini Nutrition Assessment test and registered drug information, are included in the study. The investigator calculated the DBI as the sum of all sedatives and anticholinergics taken continuously for at least four weeks prior to admission and evaluated the ACB score. Practice Impact: Due to accompanying chronic diseases and symptoms, cholinergic and/or sedative-loaded drugs are often prescribed to dementia patients. In this study, İnvestigators emphasized that in addition to the cholinergic loads of the drugs used, their sedative loads and the drug doses they use are also important. Avoiding prescribing these medications to patients with dementia will protect them from malnutrition and its negative consequences.

Who can participate

Age range

65 Years – 100 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: * Clinical diagnosis of any type of demantia * Must be able to swallow tablets * Must be recorded data of medications and doses Exclusion Criteria: * Psychiatric disorders * Mild cognitive impairment * End-stage diseases (renal, liver, cardiac) * Uncontrolled thyroid functions

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 participants with malnutrition, malnutrition risk and healthy

Timeframe: Baseline

Number of participants with high DBI (Drug Burden Index) score

Timeframe: Baseline

Number of participants with high ACB (Anti Cholinergic Burden) score

Timeframe: Baseline

Trial details

NCT IDNCT06447259

SponsorSultan Keskin Demircan

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2023-10-01

View on ClinicalTrials.gov More Malnutrition Severe trials

Plain-language summary

Who can participate

Age range

65 Years – 100 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.