Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT03208569
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2017-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anticholinergic Burden - Treatment Optimization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 663}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': '6 months', 'description': 'Mini-Mental State Examination (MMSE). Range 0-30; maximum 30 indicating preserved cognitive functioning.'}, {'measure': 'Cognitive function', 'timeFrame': '6 months', 'description': 'Montreal Cognitive Assessment (MoCA). Range 0-30; maximum 30 indicating preserved cognitive functioning.'}, {'measure': 'Cognitive function', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Cognitive function', 'timeFrame': '6 months', 'description': "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"}, {'measure': 'Cognitive function', 'timeFrame': '6 months', 'description': 'Symbol Digit Modalities Test (SDMT) Assessing attention, executive function and memory. Correctly identified symbols are recorded within a time frame of 90 seconds.\n\nAge-dependent e.g, 70-74 years of age with short education: 36. High education: 43'}, {'measure': 'Cognitive function', 'timeFrame': '6 months', 'description': 'A Quick Test of Cognitive Speed (AQT) Three moments, 1 color, 2 form and 3 color-form. Naming correctly as fast as possible.'}, {'measure': 'Cognitive function', 'timeFrame': '6 months', 'description': '5x3 Memory Test A brief and structured memory test involving 15 concrete items grouped into five items on three subsequent sets.\n\nScoring is based on immediate and delayed recall in a special scoring system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anticholinergic', 'alzheimer', 'cognition', 'MMSE', 'anticholinergic cognitive burden scale'], 'conditions': ['Anticholinergics', 'Cognitive Function']}, 'referencesModule': {'references': [{'pmid': '37626293', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/37626293/', 'label': 'Article BMC Geriatr. 2023 Aug.25;23(1):518'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes individuals aged ≥ 50 at the Memory Clinic, Hospital of Ängelholm', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50 years and older'}, 'identificationModule': {'nctId': 'NCT03208569', 'briefTitle': 'Anticholinergic Burden - Treatment Optimization', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Treatment Optimization Regarding Anticholinergic Medications Potential Impact on Cognitive Test Performance', 'orgStudyIdInfo': {'id': 'Studie ACB'}}, 'contactsLocationsModule': {'locations': [{'zip': '26281', 'city': 'Ängelholm', 'country': 'Sweden', 'facility': 'Specialistminnesmottagningen', 'geoPoint': {'lat': 56.2428, 'lon': 12.86219}}], 'overallOfficials': [{'name': 'Per Johansson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Skåne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Angelholm Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}