Association of Anticholinergic Burden With Onset of Delirium in Older Adults With Alzheimer Dementia:

Association of Anticholinergic Burden With Onset of Delirium in Older Adults With Alzheimer Dementia: A Retrospective Cohort Study

Drugs with anticholinergic properties are commonly prescribed to older persons despite growing evidence of their significant adverse effects. However, limited data are available concerning their contribution to time of onset of delirium. This study aimed to determine the potential association of higher anticholinergic burden to early-onset of delirium superimposed dementia in the older adult.

Study Overview

• Status: Recruiting
• Conditions: Delirium; Alzheimer Disease; Anticholinergic Adverse Reaction
• Intervention / Treatment: Drug: Anticholinergic burden

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06670
    • Recruiting
    • Gulhane Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All participiants enrolled from outpaitent clinic and underwent by comprehesive geriatric asssessment.

Delirium and dementia status was assessed by the criteria of confusion assessment method (CAM) and DSM-4 or DSM-5 respectively.

Description

Inclusion Criteria:

• 65 years and older and diagnosis or fellow-up of Alzhemier dementia in outpatient clinic.

Exclusion Criteria:

• The patients with a history of other than Alzhemier dementia or neurodegenerative disease (epilepsy, multiple sclerosis, Parkinson disease, etc.), terminal illness (malignancy, advanced organ failure) were excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
early onset deliryum on dementia; It was earlier than The median time of onset of delirium superimposed dementia	Drug: Anticholinergic burden; The anticholinergic burden (ACB) was assessed using the Anticholinergic Burden Scale. Higher ACB was described as equal or higher than 1.
Delirium on dementia (normal); It was equal or later than The median time of onset of delirium superimposed dementia	Drug: Anticholinergic burden; The anticholinergic burden (ACB) was assessed using the Anticholinergic Burden Scale. Higher ACB was described as equal or higher than 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time onset of delirium superimposed dementia	First attack of delirium onset	12 month

Collaborators and Investigators

• Sponsor: Gulhane Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2005
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (ACTUAL): September 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Delirium; Dementia; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Cholinergic Antagonists
• Other Study ID Numbers: 2020-383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No