AnticholinergicsNCT03208569
Anticholinergic Burden - Treatment Optimization
An observational study of Anticholinergics and Cognitive Function, run by Region Skane at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anticholinergics, Cognitive Function
- How many people
- 663 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2017to 30 Sep 2021
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes individuals aged ≥ 50 at the Memory Clinic, Hospital of Ängelholm
Who may be able to join
- 50 years and older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anticholinergics, Cognitive Function
- Keywords
- anticholinergic, alzheimer, cognition, MMSE, anticholinergic cognitive burden scale
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Mini-Mental State Examination (MMSE). Range 0-30; maximum 30 indicating preserved cognitive functioning.
Measured: 6 months
Cognitive function
Montreal Cognitive Assessment (MoCA). Range 0-30; maximum 30 indicating preserved cognitive functioning.
Measured: 6 months
Cognitive function
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.
Measured: 6 months
Cognitive function
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
Measured: 6 months
Cognitive function
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
Measured: 6 months
Cognitive function
A Quick Test of Cognitive Speed (AQT) Three moments, 1 color, 2 form and 3 color-form. Naming correctly as fast as possible.
Measured: 6 months
Cognitive function
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Sep 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnticholinergicsStudies 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
- Prospective
- Enrolment
- 663 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Angelholm Hospital
- Responsible party
- Sponsor
- Investigators
- Per Johansson, MD, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208569
- Sponsor's protocol ID
- Studie ACB
- Status last verified
- Aug 2025
- First submitted
- 27 Jun 2017
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rube T, Ecorcheville A, Londos E, Modig S, Johansson P. Development of the Swedish anticholinergic burden scale (Swe-ABS). BMC Geriatr. 2023 Aug 25;23(1):518. doi: 10.1186/s12877-023-04225-1.
PubMed 37626293Rube T, Londos E, Johansson P. Utility of the Swedish Anticholinergic Burden Scale in a memory clinic setting: a comparison with the Anticholinergic Cognitive Burden scale. Sci Rep. 2026 Jan 6;16(1):796. doi: 10.1038/s41598-025-34439-9.
PubMed 41495432
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Optimization Regarding Anticholinergic Medications Potential Impact on Cognitive Test Performance
- ClinicalTrials.gov ID
- NCT03208569
- Acronym / sponsor ID
- Studie ACB
- Conditions
- Anticholinergics, Cognitive Function
- Keywords
- anticholinergic, alzheimer, cognition, MMSE, anticholinergic cognitive burden scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 663 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Angelholm Hospital
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 5 Jul 2017 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes individuals aged ≥ 50 at the Memory Clinic, Hospital of Ängelholm
Key inclusion criteria (1 listed)
- 50 years and older
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive function
Time frame: 6 months
Mini-Mental State Examination (MMSE). Range 0-30; maximum 30 indicating preserved cognitive functioning.
Cognitive function
Time frame: 6 months
Montreal Cognitive Assessment (MoCA). Range 0-30; maximum 30 indicating preserved cognitive functioning.
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.
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Results publication: PubMed 37626293Rube T, Ecorcheville A, Londos E, Modig S, Johansson P. Development of the Swedish anticholinergic burden scale (Swe-ABS). BMC Geriatr. 2023 Aug 25;23(1):518. doi: 10.1186/s12877-023-04225-1.
- Derived from this study: PubMed 41495432Rube T, Londos E, Johansson P. Utility of the Swedish Anticholinergic Burden Scale in a memory clinic setting: a comparison with the Anticholinergic Cognitive Burden scale. Sci Rep. 2026 Jan 6;16(1):796. doi: 10.1038/s41598-025-34439-9.
- Article BMC Geriatr. 2023 Aug.25;23(1):518Link provided by the sponsor.
- 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.
Per Johansson, MD, PhD principal investigator
Region Skane
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 Anticholinergics and Cognitive Function, run by Region Skane at 1 site in Sweden.
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 0 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: finished, as of the sponsor's last update on 28 Aug 2025. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03208569, which also lists 2 linked publications.
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 28 Aug 2025.