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Anticholinergic Burden - Treatment Optimization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208569
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Angelholm Hospital
Information provided by (Responsible Party):
Region Skane

Brief 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.

Condition or disease
Anticholinergics Cognitive Function

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Optimization Regarding Anticholinergic Medications Potential Impact on Cognitive Test Performance
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021



Primary Outcome Measures :
  1. Cognitive function [ Time Frame: 6 months ]
    Cognitive function, measured by the Mini-Mental State Examination (MMSE)


Secondary Outcome Measures :
  1. Anticholinergic burden [ Time Frame: 6 months ]
    Anticholinergic burden, determined according to the Anticholinergic Burden scale

  2. Cognitive function [ Time Frame: 6 months ]
    Cognitive function, measured by Montreal Cognitive Assessment (MOCA)

  3. Cognitive function [ Time Frame: 6 months ]
    Cognitive function, measured by the Trail Making Test A & B (TMT)

  4. Cognitive function [ Time Frame: 6 months ]
    Cognitive function, measured by The Alzheimer´s Disease Assessment Scale - Cognitive subscale (ADAS-Cog)

  5. Cognitive function [ Time Frame: 6 months ]
    Cognitive function, measured by the Symbol Digit Modalities Test (SDMT)

  6. Cognitive function [ Time Frame: 6 months ]
    Cognitive function, measured by A Quick Test of cognitive speed (AQT)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population includes individuals aged ≥ 50 at the Memory Clinic, Hospital of Ängelholm
Criteria

Inclusion Criteria:

  • 50 years and older

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208569


Contacts
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Contact: Per Johansson, MD, PhD +46(0)709-105103 per.m.johansson@skane.se
Contact: Tanja Rube, MScPharm +46(0)431-81597 tanja.rube@skane.se

Locations
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Sweden
Specialistminnesmottagningen Recruiting
Ängelholm, Sweden, 26281
Contact: Per Johansson, MD,PhD    +46 431-815 74    per.m.johansson@skane.se   
Contact: Tanja Rube, MScPharm    +46 431-815 97      
Sponsors and Collaborators
Region Skane
Angelholm Hospital
Investigators
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Principal Investigator: Per Johansson, MD, PhD Region Skåne
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03208569    
Other Study ID Numbers: Studie ACB
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Skane:
anticholinergic
alzheimer
cognition
MMSE
anticholinergic cognitive burden scale