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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03208569
Other study ID # Studie ACB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date September 30, 2021

Study information

Verified date October 2021
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There is increasing evidence that medications with anticholinergic effects may adversely affect cognitive function. Older adults are particularly sensitive to anticholinergic effects because of changes in pharmacokinetics and pharmacodynamics. The cumulative effect of taking one or more medicines with anticholinergic properties is referred to as anticholinergic burden. To estimate the anticholinergic burden, Boustani et al. published the Anticholinergic Cognitive Burden scale (2008). The objective of this study is to measure the association between the use of medications with anticholinergic properties (identified by the ACB scale) and cognitive performance. Anticholinergic use and cognitive performance will be measured at baseline and 6-months follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 665
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - 50 years and older

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Specialistminnesmottagningen Ängelholm

Sponsors (2)

Lead Sponsor Collaborator
Region Skane Angelholm Hospital

Country where clinical trial is conducted

Sweden, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive function Cognitive function, measured by the Mini-Mental State Examination (MMSE) 6 months
Secondary Anticholinergic burden Anticholinergic burden, determined according to the Anticholinergic Burden scale 6 months
Secondary Cognitive function Cognitive function, measured by Montreal Cognitive Assessment (MOCA) 6 months
Secondary Cognitive function Cognitive function, measured by the Trail Making Test A & B (TMT) 6 months
Secondary Cognitive function Cognitive function, measured by The Alzheimer´s Disease Assessment Scale - Cognitive subscale (ADAS-Cog) 6 months
Secondary Cognitive function Cognitive function, measured by the Symbol Digit Modalities Test (SDMT) 6 months
Secondary Cognitive function Cognitive function, measured by A Quick Test of cognitive speed (AQT) 6 months
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