Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial (IMPACT2)

• ClinicalTrials.gov Identifier: NCT02781220
• Recruitment Status: Active, not recruiting
• First Posted: May 24, 2016
• Last Update Posted: January 28, 2020
• Sponsor: University of Utah
• Information provided by (Responsible Party): Norman Foster, University of Utah

Study Description

Brief Summary:

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.

Condition or disease
Mild Cognitive Impairment; Dementia; Alzheimer's Disease

Detailed Description:

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

Study Design

• Study Type: Observational
• Actual Enrollment: 69 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial
• Study Start Date: July 2016
• Actual Primary Completion Date: July 2018
• Estimated Study Completion Date: July 2021

Groups and Cohorts

Group/Cohort
Qualifying participants; 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

Outcome Measures

Primary Outcome Measures :

1. Percentage of change in care practices after amyloid PET scan [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
   % of 13 care practices that differ before and after the amyloid PET scan

Secondary Outcome Measures :

1. Percentage of change in drug management options after amyloid PET [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
   % of drug management options that differ before and after the amyloid PET scan
2. Change in % likelihood of Alzheimer's disease (AD) diagnosis after amyloid PET scan [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
   Difference in % of AD likelihood identified before and after the amyloid PET scan
3. Percentage of change in leading diagnosis after amyloid PET [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
   % of leading diagnosis that differ before and after amyloid PET scan
4. Change in physician confidence in leading diagnosis [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
   Difference in 5-point scale of physician confidence in leading diagnosis before and after amyloid PET scan
5. Change in care partner's confidence in diagnosis after amyloid PET [ 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 ]
   Difference in 5-point scale of care partner confidence in diagnosis before and after amyloid PET scan
6. Change in care partner satisfaction with evaluation after amyloid PET [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
   Difference in 5-point scale of care partner satisfaction before team care and after amyloid PET scan
7. Change in care partner assessment of the quality of evaluation after amyloid PET [ Time Frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan ]
   Difference in 5-point scale of care partner quality before team care and after amyloid PET scan
8. Proportion of care partners finding amyloid PET scan worthwhile [ Time Frame: Visit 4, 90 days after scan ]
   Proportion of care partners indicating they would agree to do an amyloid PET again on a yes/no/don't know scale
9. Proportion exhibiting increased behavior disturbance during amyloid scan visit [ Time Frame: Visit 1, Visit 2, Visit 3, and Visit 4 90 days post scan ]
   % 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
10. Percentage of change exhibiting increased behavior disturbance when the diagnosis is given [ Time Frame: Visit 1, Visit 3, 60 days ]
    % 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
11. Care partner's sustained confidence in diagnosis received after amyloid PET scan [ Time Frame: Visit 4, Visit 5, and Visit 6, 270 days post scan ]
    Care partner confidence in diagnosis received after amyloid PET scan on a 5-point scale
12. Care partner's sustained confidence in ability to adhere to management plan received after amyloid PET scan [ Time Frame: Visit 4, Visit 5, and Visit 6, 270 days post scan ]
    Care partner confidence in ability to follow management plan outlined by physician after amyloid PET scan on a 5-point scale
13. Percentage of recommended care practices adhered to after amyloid PET scan [ Time Frame: Visit 4, Visit 5, and Visit 6, 270 days post scan ]
    % of care practices recommended after amyloid PET scan reported by care partner
14. Percentage of recommended drug management adhered to after amyloid PET scan [ Time Frame: Visit 4, Visit 5, and Visit 6, 270 days post scan ]
    % of drug management options recommended after amyloid PET scan reported by care partner

Other Outcome Measures:

1. Change in the interpretation of amyloid PET scans with semi-quantitative image analysis [ Time Frame: within 30 days post amyloid PET scan ]
   Difference in a 5-point measure of amyloid scan positivity between a qualitative and semi-quantitative image analysis

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Participants must be Medicare beneficiaries referred by qualified dementia specialists and must meet AUC for amyloid PET (Johnson et al. 2013).

Criteria

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.

Contacts and Locations

Locations

United States, Utah

Center for Alzheimer's Care, Imaging & Research

Salt Lake City, Utah, United States, 84108-1225

Sponsors and Collaborators

University of Utah

Investigators

• Principal Investigator: Norman L. Foster, M.D.; Director: Center for Alzheimer's Care, Imaging & Research; Chief: Division of Cognitive Neurology; Senior Investigator: The Brain Institute; Professor: Dept. of Neurology University of Utah School of Medicine

More Information

Additional Information:

General Electric Healthcare. Vizamyl Package Insert. Accessed 03/04/2014 

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• Responsible Party: Norman Foster, Director: Center for Alzheimer's Care, Imaging & Research; Chief: Division of Cognitive Neurology; Senior Investigator: The Brain Institute; Professor: Dept. of Neurology University of Utah School of Medicine, University of Utah
• ClinicalTrials.gov Identifier: NCT02781220
• Other Study ID Numbers: IMPACT-2
• First Posted: May 24, 2016
• Last Update Posted: January 28, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: only de-identified data will be shared

Keywords provided by Norman Foster, University of Utah:

MCI; Dementia; amyloid PET; physician diagnosis; Alzheimer's disease; AD; PET imaging; Appropriate Use Criteria; patient-reported outcomes; patient adherence

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Cognitive Dysfunction; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders