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

Contact Information

Rorie Duprey

Simple Summary

The purpose of this study is to examine how undergoing a brain imaging scan may impact diagnosis and treatment of patients with Mild Cognitive Impairment or dementia of unclear etiology.

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

Participant Reimbursement

There is no monetary compensation for participation in this study.