Anticholinergic Burden - Treatment Optimization

NCT03208569 | Completed

• 1 other identifier: Studie ACB
• Study Type: observational
• Target: 663
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (7)

• Cognitive function

  Mini-Mental State Examination (MMSE). Range 0-30; maximum 30 indicating preserved cognitive functioning.

  6 months

• Cognitive function

  Montreal Cognitive Assessment (MoCA). Range 0-30; maximum 30 indicating preserved cognitive functioning.

  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.

  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

  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

  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.

  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.

  6 months

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• years and older

Sponsors & Collaborators

• Region Skane: lead
• Angelholm Hospital: collaborator

Study Sites (1)

Specialistminnesmottagningen

Ängelholm, 26281, Sweden

Location

Related Publications (1)

• 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.

  PMID: 37626293 RESULT

Related Links

• Article BMC Geriatr. 2023 Aug.25;23(1):518

Study Officials

• Per Johansson, MD, PhD

  Region Skåne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 5, 2017
• Study Start: September 1, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)