Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial

Conditions
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Mild Cognitive Impairment, Dementia, Alzheimer's Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 and older; Medicare beneficiary; Diagnosis of mild cognitive impairment (MCI) or dementia, according to Diagnostic and Statistical Manual - IV (DSM-IV) and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months (American Psychiatric Association. 2000; McKhann et al. 2011; Albert et al. 2011); Meets AUC: Cognitive complaint verified by objectively confirmed cognitive impairment; The etiologic cause of cognitive impairment is uncertain after a comprehensive evaluation by a dementia specialist, including general medical and neurological examination, mental status testing including standard measures of cognitive impairment, laboratory testing, and structural neuroimaging as below; Alzheimer's disease is a diagnostic consideration; Knowledge of amyloid PET status is expected to alter diagnosis and management. Head MRI and/or CT within 24 months prior to enrollment; Clinical laboratory assessment within the 12 months prior to enrollment: complete blood count (CBC), standard blood chemistry profile, thyroid stimulating hormone (TSH); vitamin B12; Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility; English or Spanish speaking (for the purposes of informed consent); Willing and able to provide consent. Consent may be by proxy. Exclusion Criteria: Normal cognition or subjective complaints that are not verified by cognitive testing. Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family. Scan is being ordered solely based on a family history of dementia, presence of apolipoprotein E, or in lieu of genotyping for suspected autosomal mutation carriers. Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening). Cancer requiring active therapy (excluding non-melanoma skin cancer); Hip/pelvic fracture within the 12 months prior to enrollment; Body weight exceeds PET scanner weight limit; Life expectancy less than 24 months based on medical co-morbidities; Residence in a skilled nursing facility.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Qualifying participants<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change in care practices after amyloid PET scan | % of 13 care practices that differ before and after the amyloid PET scan | Visit 1, 30 days prior to scan and Visit 4, 90 days after scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change in drug management options after amyloid PET | % of drug management options that differ before and after the amyloid PET scan | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Visit 4, Visit 5, and Visit 6, 270 days post scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCI, Dementia, amyloid PET, physician diagnosis, Alzheimer's disease, AD, PET imaging, Appropriate Use Criteria, patient-reported outcomes, patient adherence