Association of Anticholinergic Burden With Onset of Delir... | NCT05055895

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

NCT05055895

Sponsor

Gulhane Training and Research Hospital

Status

Unknown status

Last Update Posted

Sep 24, 2021Actual

Enrollment

450Estimated

Phase

Not provided

Conditions

Delirium
Anticholinergic Adverse Reaction
Alzheimer Disease

Interventions

Anticholinergic burden

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2005Actual

Primary Completion Date

Jun 2021Actual

Completion Date

Dec 2022Estimated

First Submitted Date

Sep 15, 2021

First Submission Date that Met QC Criteria

Sep 15, 2021

First Posted Date

Sep 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2021

Last Update Posted Date

Sep 24, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bilal Katipoglu, Geriatric, Gulhane Training and Research HospitalPrincipal Investigator

Lead Sponsor

Gulhane Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
early onset deliryum on dementia		It was earlier than The median time of onset of delirium superimposed dementia	Drug: Anticholinergic burden
Delirium on dementia (normal)		It was equal or later than The median time of onset of delirium superimposed dementia	Drug: Anticholinergic burden

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anticholinergic burden	Drug	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)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gulhane training and research hospital	Recruiting	Ankara		06670	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided