Implications for Management of PET Amyloid Classification Technology
Condition: Mild Cognitive Impairment; Dementia; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction
Study type: Observational

Summary: 
      The main purpose of this study is to explore the impact of an amyloid positron emission
      tomography and computed tomography (PET/CT) scan on physician diagnosis and management,
      including drug management and care practices, for patients with a diagnosis of cognitive
      impairment. This study also intends to capture specific patient-reported outcomes related to
      patient burden, confidence and satisfaction.

      The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain
      etiology for their dementia will benefit from knowledge of amyloid plaque burden status,
      through an alteration of patient diagnosis and management, which will lead to significant
      changes in patient and care partner reported outcomes.
    

Detailed description: 
      The primary purpose of this prospective, observational study is to examine the benefit of
      [18F]Flutemetamol PET/CT scan in clinical practice for early diagnosis of cognitive
      impairment and identifying Alzheimer's disease (AD) pathology. To accomplish this, when a
      clinician has ordered an amyloid positron emission tomography (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.

      Aims:

      Aim 1: To assess the change in diagnosis and management including both 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 the confidence of visual interpretation by using vendor supplied
      semi-quantitative software to assess amyloid plaque burden.

      Hypotheses to be Tested - Synopsis The hypothesis is that to aid early diagnosis, individuals
      with a diagnostically uncertain etiology for their dementia will benefit from knowledge of
      amyloid plaque burden status through an alteration of patient diagnosis and management, which
      will lead to significant changes in patient and care partner reported outcomes.

      Aim 1

        1. Amyloid PET will change physician judgment of the likelihood of AD

        2. Amyloid PET will change the leading diagnosis in more than 25% of cases

        3. Amyloid PET will increase physician diagnostic confidence in the leading diagnosis

        4. Amyloid PET will change more than 25% of care practice options from pre-scan management

        5. Amyloid PET will change more than 25% of drug management options

      Aim 2

        1. Care partners are more confident in the diagnosis after the scan than before the scan

        2. Care partners will be more satisfied with multidisciplinary cognitive specialty team
           evaluation than previous evaluation

        3. Care partners will be more satisfied with multidisciplinary cognitive specialty team
           evaluation with amyloid PET than than the evaluation non-specialists performed without
           amyloid PET

        4. Care partners will find amyloid PET not very burdensome if the doctor finds a scan
           helpful

        5. Based upon their experience with the amyloid PET scan, a majority of the care partners
           would still agree to have an amyloid PET scan performed if it were requested by the
           specialist

        6. Care partners will find that amyloid PET did not cause an increase in adverse reactions
           (scan visit) than standard routine clinic visit (post-scan visit)

        7. Care partners will find that the diagnostic clinic visit (post-scan visit) did not cause
           an increase in adverse reactions than the first clinic visit (pre-scan visit)

      Aim 3:

      1. Confidence of radiologist / nuclear medicine physician interpretation of scans increases
      after adding quantitative analysis as compared to qualitative analysis alone

      This study will use [18F]Flutemetamol-PET imaging to assess and quantify the amyloid plaque
      burden in patients with mild cognitive impairment (MCI) or dementia of unclear etiology,
      according to Diagnostic Statistical Manual-IV (DSM-IV) and/or National Institutes of
      Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.

      The [18F]Flutemetamol-PET scans of these study participants will then be assessed using a
      General Electric (GE) software databases (NeuroMarQ) which contain scan data from healthy
      control individuals to evaluate for abnormalities in amyloid plaque burden differing from the
      values expected for individuals in their age range.
    

Intervention name(s): [18F]Flutemetamol
Intervention type(s): Drug
Intervention description(s): amyloid PET imaging with [18F]Flutemetamol and subsequent modification of diagnosis and management
Other intervention name(s): Vizamyl
Intervention MeSH terms: Flutemetamol
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants: Adults 45-90 years of age with a confirmed diagnosis of MCI or
        dementia, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association
        criteria, verified by a dementia specialist within 24 months.
      
Keywords: MCI; Dementia; amyloid PET; physician diagnosis; Alzheimer's disease; AD; PET imaging; Appropriate Use Criteria; patient-reported outcomes