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

Utah System of Higher Education (USHE)

Status: Terminated

Conditions: Alzheimer's Disease; Mild Cognitive Impairment; Dementia

Study type: Observational

Funder types: Other

Identifiers

NCT02781220

90351

Details and patient eligibility

About

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.

Full 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

Enrollment: 69 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

69 participants in 1 patient group

Qualifying participants

Description:

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