- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03208569
Anticholinergic Burden - Treatment Optimization
Treatment Optimization Regarding Anticholinergic Medications Potential Impact on Cognitive Test Performance
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ängelholm, Sweden, 26281
- Specialistminnesmottagningen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 50 years and older
Study Plan
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
|
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Per Johansson, MD, PhD, Region Skane
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Studie ACB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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