Anticholinergic Burden - Treatment Optimization

August 21, 2025 updated by: Region Skane

Treatment Optimization Regarding Anticholinergic Medications Potential Impact on Cognitive Test Performance

There is increasing evidence that medications with anticholinergic effects may adversely impact cognitive function. Older adults are particularly sensitive to these effects due to age-related changes in pharmacokinetics and pharmacodynamics. The cumulative impact of taking one or more medications with anticholinergic properties is known as the anticholinergic burden. To quantify this burden, Boustani et al. (2008) developed the Anticholinergic Cognitive Burden (ACB) scale. The objective of this study is to examine whether optimizing pharmacotherapy concerning drugs with anticholinergic effects-identified by both the ACB scale and the newly developed Swe-ABS-can improve cognitive test performance among individuals attending a memory clinic. Anticholinergic drug use and cognitive performance will be assessed at baseline and at a 6-month follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
663

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Ängelholm, Sweden, 26281
        • Specialistminnesmottagningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study population includes individuals aged ≥ 50 at the Memory Clinic, Hospital of Ängelholm

Description

Inclusion Criteria:

  • 50 years and older

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: 6 months
Mini-Mental State Examination (MMSE). Range 0-30; maximum 30 indicating preserved cognitive functioning.
6 months
Cognitive function
Time Frame: 6 months
Montreal Cognitive Assessment (MoCA). Range 0-30; maximum 30 indicating preserved cognitive functioning.
6 months
Cognitive function
Time Frame: 6 months
Trail Making Test (TMT) - A. Assessing visual attention and processing speed. Age-dependent e.g, 65-74 years of age 33 ± 11 seconds. Trail Making Test (TMT) - B. Assessing executive function especially cognitive flexibiity. Age-dependent e.g, 65-74 years of age 85 ± 25 seconds.
6 months
Cognitive function
Time Frame: 6 months
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Neuropsychological test battery covering several cognitive domains. Age-dependent e.g, 70-79 years of age with education < 6 years: 12-16. High education: 8-12
6 months
Cognitive function
Time Frame: 6 months

Symbol Digit Modalities Test (SDMT) Assessing attention, executive function and memory. Correctly identified symbols are recorded within a time frame of 90 seconds.

Age-dependent e.g, 70-74 years of age with short education: 36. High education: 43
6 months
Cognitive function
Time Frame: 6 months
A Quick Test of Cognitive Speed (AQT) Three moments, 1 color, 2 form and 3 color-form. Naming correctly as fast as possible.
6 months
Cognitive function
Time Frame: 6 months

5x3 Memory Test A brief and structured memory test involving 15 concrete items grouped into five items on three subsequent sets.

Scoring is based on immediate and delayed recall in a special scoring system.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anticholinergic burden
Time Frame: 6 months
Anticholinergic burden, determined according to the Anticholinergic Burden scale
6 months
Cognitive function
Time Frame: 6 months
Cognitive function, measured by Montreal Cognitive Assessment (MOCA)
6 months
Cognitive function
Time Frame: 6 months
Cognitive function, measured by the Trail Making Test A & B (TMT)
6 months
Cognitive function
Time Frame: 6 months
Cognitive function, measured by The Alzheimer´s Disease Assessment Scale - Cognitive subscale (ADAS-Cog)
6 months
Cognitive function
Time Frame: 6 months
Cognitive function, measured by the Symbol Digit Modalities Test (SDMT)
6 months
Cognitive function
Time Frame: 6 months
Cognitive function, measured by A Quick Test of cognitive speed (AQT)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Angelholm Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Per Johansson, MD, PhD, Region Skane

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Studie ACB

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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