IMPACT

Principal Investigator: Norman Foster
Keywords: Mild Cognitive Impairment , Futemetamol PET Department: Alzheimer's Center
IRB Number: 00084919 Co Investigator:  
Specialty: Neurology, Neurology, Neurology, Neurology
Sub Specialties: Neuroimaging, Dementia, Alzheimer's Disease, Cognitive Disorders
Recruitment Status: Not yet recruiting

Contact Information

Rorie Duprey
rorie.duprey@hsc.utah.edu
801-585-0925

Brief Summary

Purpose of Study

The primary purpose of this prospective, observational study is to examine the benefit of adding a [18F]Flutemetamol PET/CT scan to clinical practice for early diagnosis of Alzheimer’s disease (AD). To accomplish this, we 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 evaluated in the Cognitive Disorders Clinic at the University of Utah and meeting Appropriate Use Criteria (AUC) for use of clinical amyloid PET/CT scans. A secondary purpose is to assess the impact of a semi-quantitative assessment of amyloid plaque burden using vendor supplied software versus the 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 of Study

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 the confidence of visual interpretation by using vendor supplied semi-quantitative software to assess amyloid plaque burden. 

Aim 4: To assess adherence to identified patient management related to care practices and drug management.

 

 

Inclusion Criteria

Participant Eligibility

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.

Inclusion Criteria

  • Patients must be 45 to 90 years of age for inclusion in this research study.
  • Confirmed diagnosis of MCI or dementia of unclear etiology, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
  • Meets Appropriate Use Criteria (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.
  • MRI and/or CT of the brain within 24 months prior to enrollment;
  • Clinical laboratory assessment (complete blood count [CBC], standard blood chemistry profile, thyroid stimulating hormone [TSH], vitamin B12) within the 12 months prior to enrollment;
  • Patient must agree to have clinical and radiographic endpoints and the results of and other laboratory information entered into a research database, as evidenced by signing the informed consent form.
  • Patient must be postmenopausal for a minimum of one year, surgically sterile, or has been confirmed not to be pregnant by serum pregnancy test performed within 24 hours prior to research PET imaging.
  • All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.

Exclusion Criteria

Exclusion Criteria

  • Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator’s discretion.
  • Adult patients who require monitored anesthesia for PET scanning.
  • Patients who are too claustrophobic to undergo PET imaging.
  • Prior participation in any clinical drug trial directed to remove or prevent amyloid pathology.
  • Patients with Normal cognition or subjective complaints that are not verified by cognitive testing.
  • Subject's scans being ordered for one of the following reasons:
  • 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)
  • Currently pregnant
  • Patients who are unwilling to know the results of their PET imaging scan