DeliriumNCT05055895
Association of Anticholinergic Burden With Onset of Delirium in Older Adults With Alzheimer Dementia:
An observational study of Delirium and Anticholinergic Adverse Reaction, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Anticholinergic Adverse Reaction, Alzheimer Disease
- What is being tested?
- Anticholinergic burden
- How many people
- 450 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2005to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- 65 years and older and diagnosis or fellow-up of Alzhemier dementia in outpatient clinic.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gulhane training and research hospital
Ankara, 06670
Bilal Katipoglu, MD, +905543330380, drbilal07@gmail.com
Mehmet I Naharcı, Prof
About this study
Official title: 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.
- Being tested
- Anticholinergic burden
- Medical subject headings
- Delirium, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticholinergic burdenDrug
The anticholinergic burden (ACB) was assessed using the Anticholinergic Burden Scale.
Higher ACB was described as equal or higher than 1.
| Study group | Role | What they receive |
|---|---|---|
| early onset deliryum on dementia | It was earlier than The median time of onset of delirium superimposed dementia Receives: Drug: Anticholinergic burden | |
| Delirium on dementia (normal) | It was equal or later than The median time of onset of delirium superimposed dementia Receives: Drug: Anticholinergic burden |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time onset of delirium superimposed dementia
First attack of delirium onset
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Jan 2005
- Primary completionJun 2021
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bilal Katipoglu, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055895
- Sponsor's protocol ID
- 2020-383
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Anticholinergic Burden With Onset of Delirium in Older Adults With Alzheimer Dementia: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05055895
- Acronym / sponsor ID
- 2020-383
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early onset deliryum on dementia | – | Drug: Anticholinergic burdenIt was earlier than The median time of onset of delirium superimposed dementia |
| Delirium on dementia (normal) | – | Drug: Anticholinergic burdenIt was equal or later than The median time of onset of delirium superimposed dementia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 65 years and older and diagnosis or fellow-up of Alzhemier dementia in outpatient clinic.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticholinergic burdenThe anticholinergic burden (ACB) was assessed using the Anticholinergic Burden Scale. Higher ACB was described as equal or higher than 1. | Drug | Delirium on dementia (normal), early onset deliryum on dementia |
Primary outcome
Time onset of delirium superimposed dementia
Time frame: 12 month
First attack of delirium onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Anticholinergic Adverse Reaction, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time onset of delirium superimposed dementia (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.