Implications for Management of PET Amyloid Classification Technology

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Treatments: Flutemetamol

Criteria

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 12 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;

• 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:

• 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 an amyloid vaccination clinical study at any time in the past or completion of a passive amyloid vaccination study within 6 months before screening.

• 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.