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

Completed

Study Type

Observational

Enrollment (Actual)

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

      • 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

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

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

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

Collaborators

Investigators

  • 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.

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)

September 1, 2017

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 5, 2017

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

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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