An observational study in Mild Cognitive Impairment, Dementia and Alzheimer's Disease, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by University of Utah · Observational
The main purpose of this study is to build upon the evidence captured in the Imaging Dementia - Evidence for Amyloid Scanning (IDEAS; NCT02420756) trial to include valuable information regarding patient-reported outcomes and physician confidence in diagnosis and management based on the Implications for Management of PET Amyloid Classification Technology (IMPACT; NCT number not yet assigned) trial design.
The primary purpose of this prospective, observational study is to examine the benefit of amyloid positron emission tomography and computed tomography (PET/CT) scan in clinical practice for participants at our site that are enrolled in the IDEAS (NCT02420756) trial. To accomplish this, when a clinician has ordered an amyloid PET scan, the investigators will assess the impact of [18F]Flutemetamol PET/CT scans on 1) physician diagnosis and management as it relates to care practices and drug management, and 2) patient reported outcomes in patients evaluated in the Cognitive Disorders Clinic at the University of Utah and meeting Appropriate Use Criteria (AUC) for clinical amyloid PET/CT scans. A secondary purpose is to compare the semi-quantitative assessment of amyloid plaque burden using vendor supplied software and standard visual assessment of amyloid positivity.
The primary hypothesis is that, in diagnostically uncertain cases, knowledge of amyloid status as determined by amyloid PET/CT scans may alter patient diagnosis and management and lead to significant changes in patient and family reported outcomes. A secondary hypothesis is that vendor supplied semi-quantitative assessment of amyloid plaque positivity will be superior to standard visual criteria assessments.
Objectives
AIM 1: to assess the change in diagnosis and management, related to care practices and drug management of adult patients being evaluated for cognitive deficits and meeting Appropriate Use Criteria (AUC)
AIM 2: to assess the change of amyloid PET/ CT scans on patient-reported outcomes involving care partner confidence and satisfaction
AIM 3: to assess confidence increase through use of vendor supplied semi-quantitative software
AIM 4: to assess adherence to identified patient management related to care practices and drug management
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 69 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants must be Medicare beneficiaries referred by qualified dementia specialists and must meet AUC for amyloid PET (Johnson et al. 2013).
Exclusion Criteria:
All consented IDEAS trial participants will have additional data collected: visual and semi-quantitative software aided amyloid PET scan interpretation, care partner questionnaires and documented provider diagnosis, diagnostic confidence, and management plan following the IMPACT design
Percentage of change in care practices after amyloid PET scan
% of 13 care practices that differ before and after the amyloid PET scan
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Percentage of change in drug management options after amyloid PET
% of drug management options that differ before and after the amyloid PET scan
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in % likelihood of Alzheimer's disease (AD) diagnosis after amyloid PET scan
Difference in % of AD likelihood identified before and after the amyloid PET scan
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Percentage of change in leading diagnosis after amyloid PET
% of leading diagnosis that differ before and after amyloid PET scan
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in physician confidence in leading diagnosis
Difference in 5-point scale of physician confidence in leading diagnosis before and after amyloid PET scan
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in care partner's confidence in diagnosis after amyloid PET
Difference in 5-point scale of care partner confidence in diagnosis before and after amyloid PET scan
Time frame: Visit 1, 30 days prior to scan, Visit 4, 90 days after scan, Visit 5, 180 days after scan and Visit 6, 270 days after scan
Change in care partner satisfaction with evaluation after amyloid PET
Difference in 5-point scale of care partner satisfaction before team care and after amyloid PET scan
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in care partner assessment of the quality of evaluation after amyloid PET
Difference in 5-point scale of care partner quality before team care and after amyloid PET scan
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Proportion of care partners finding amyloid PET scan worthwhile
Proportion of care partners indicating they would agree to do an amyloid PET again on a yes/no/don't know scale
Time frame: Visit 4, 90 days after scan
Proportion exhibiting increased behavior disturbance during amyloid scan visit
% of patients showing a difference in the 44-point Catastrophic Reaction Scale between the median value in all non-scan visits and the value in the amyloid PET scan visit
Time frame: Visit 1, Visit 2, Visit 3, and Visit 4 90 days post scan
Percentage of change exhibiting increased behavior disturbance when the diagnosis is given
% of patients showing a difference in the 44-point Catastrophic Reaction Scale between Visit 1 and Visit 3 when learning the result of the scan
Time frame: Visit 1, Visit 3, 60 days
Care partner's sustained confidence in diagnosis received after amyloid PET scan
Care partner confidence in diagnosis received after amyloid PET scan on a 5-point scale
Time frame: Visit 4, Visit 5, and Visit 6, 270 days post scan
Care partner's sustained confidence in ability to adhere to management plan received after amyloid PET scan
Care partner confidence in ability to follow management plan outlined by physician after amyloid PET scan on a 5-point scale
Time frame: Visit 4, Visit 5, and Visit 6, 270 days post scan
Percentage of recommended care practices adhered to after amyloid PET scan
% of care practices recommended after amyloid PET scan reported by care partner
Time frame: Visit 4, Visit 5, and Visit 6, 270 days post scan
Percentage of recommended drug management adhered to after amyloid PET scan
% of drug management options recommended after amyloid PET scan reported by care partner
Time frame: Visit 4, Visit 5, and Visit 6, 270 days post scan
Change in the interpretation of amyloid PET scans with semi-quantitative image analysis
Difference in a 5-point measure of amyloid scan positivity between a qualitative and semi-quantitative image analysis
Time frame: within 30 days post amyloid PET scan
Plan to share: Undecided — only de-identified data will be shared
This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of Utah