Skip to main content
OpenTrials
Completed

NCT Number: NCT06447259

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sultan Keskin Demircan

Ankara, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants with malnutrition, malnutrition risk and healthy

    Time frame: Baseline

    Based on the MNA-SF score, each participant was assigned to one of the following three groups: malnutrition (score between 0 and 7), malnutrition risk (score between 8 and 11), and healthy (score from 12 to 14).

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

    Time frame: Baseline

    Medications taken consistently at least four weeks prior to admission were considered to be in current use. DBI of drugs containing sedative and cholinergic load was calculated The following formula was used to calculate the DBI = D/ (δ +D), where D represents the daily dose consumed by participants and δ is the minimum recommended is the minimum daily dose that has been established in accordance with the adult dose authorized by the US Food and Drug Administration (FDA) and Turkish authorities in the product information of the drug. Each participant's total DBI score was determined by adding the DBI values for each substance with anticholinergic or sedative effects. Patients were classified as none (DBI=0), low exposure (0<DBI<1), or high exposure (DBI ≥1).

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

    Time frame: Baseline

    Medications taken consistently at least four weeks prior to admission were considered to be in current use.The anticholinergic drug exposure in each patient was assessed by a clinician using the Anticholinergic Cognitive Burden Scale, which grades the anticholinergic activity of each drug into three categories: absence (ACB = 0), possible (ACB = 1), and definite (either ACB = 2 or ACB = 3). The scores for each drug were added up to determine the patient's overall ACB score. All patients were then categorized into three groups: none (ACB score of 0), low to moderate exposure (ACB score of 1 or 2), or high exposure (ACB score of 3 or above)

Sponsors and collaborators

Lead sponsor

Sultan Keskin Demircan

Other Gov

Registry information

Official study title

A Rising Drug Burden Index, Not Anticholinergic Burden, is Related With Malnutrition in Community-dwelling Older Adults With Dementia

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2024
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.