Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial
NCT ID: NCT02781220
Last Updated: 2024-12-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Total Enrollment
69 participants
Study Classification
OBSERVATIONAL
Study Start Date
2016-07-31
Study Completion Date
2023-06-10
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
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
Conditions
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Mild Cognitive Impairment
Dementia
Alzheimer's Disease
Keywords
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MCI
Dementia
amyloid PET
physician diagnosis
Alzheimer's disease
AD
PET imaging
Appropriate Use Criteria
patient-reported outcomes
patient adherence
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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.
* 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.
* 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.
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Utah
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Norman L. Foster, M.D.
Role: PRINCIPAL_INVESTIGATOR
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
Locations
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Center for Alzheimer's Care, Imaging & Research
Salt Lake City, Utah, United States
Site Status
Countries
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United States
References
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BACKGROUND
Wolk DA, Duara R, Sadowsky C. [18F]Flutemetamol Amyloid PET Imaging: Outcome of a Phase III Study in Subjects with Amnestic Mild Cognitive Impairment after a 3-Year Follow-Up. Alzheimer's & Dementia. 2014;4(10):P898.
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Hanseeuw B, Dricot L, Grandin C, Lhommel R, Quenon L, Ivanoiu A. Regional Brain Metabolism and Cortical Thickness in F18-Flutemetamol Amyloid-Positive Versus-Negative Mild Cognitve Impariment Patients. Alzheimer's & Dementia. 2014;10(4):P167-P168.
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Schaeverbeke J, Adamczuk K, Bruffaerts R, et al. Comparison of 18F-Flutemetamol Uptake and CSF Measurements in Cognitively Intact Older Individuals. Alzheimer's & Dementia. 2014;4(10):P144.
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AAPM Report No. 96: The Measurement, Reporting, and Management of Radiation Dose in CT. Report of AAPM Task Group 23 of the Diagnostic Imaging Council CT Committee. College Park, MD: American Association of Physicists in Medicine; 2008.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
90351
Identifier Type: -
Identifier Source: org_study_id