Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.
Condition: Alzheimer's Disease; Frontotemporal Dementia
MeSH terms: Alzheimer Disease; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Intervention: florbetapir 18F; 18F-FDG
Intervention description: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.; FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Study 18F-AV-45-010 is designed to evaluate the cerebral uptake of florbetapir 18F as
      measured by PET imaging in frontotemporal disorder (FTD) in comparison to cognitively normal
      volunteers and subjects with Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

        AD:

          -  Male or female >= 50 years of age

          -  Meet National Institute of Neurological and Communicative Disorders and Stroke
             (NINCDS) criteria for probable AD and have a Mini Mental State Examination (MMSE)
             score at screening between 10 and 24 inclusive

          -  Have a caregiver who can report on their mental status and activities of daily living
             (ADL)

          -  Give informed consent or have a caregiver give consent with subject assent.

        FTD:

          -  Male or female >= 45 years of age

          -  Meet consensus criteria for FTD and have mild to moderate disease severity. Have a
             caregiver who can report on their mental status and ADL

          -  Give informed consent or have a caregiver give consent with subject assent.

        CN:

          -  Male or female >= 45 years of age

          -  Have and MMSE >= 29

          -  Give informed consent

        Exclusion Criteria:

          -  Have a history or a current clinically significant neurologic disease (other than AD
             or FTD, as applicable), a diagnosis of other dementing/neurodegenerative disease, or a
             diagnosis of mixed dementia

          -  Evidence from MRI or other biomarkers that suggests an etiology of dementia other than
             AD or FTD, as applicable or in the case of CN subjects evidence indicating the
             presence of AD, FTD or other types of neurologic pathology

          -  Have current clinically significant cardiovascular disease, screening ECG
             abnormalities, psychiatric disease, endocrine or metabolic disease, pulmonary, renal
             or hepatic impairment, cancer or infectious disease

          -  Have a recent history of alcohol or substance abuse or dependence

          -  Women of childbearing potential who are not permanently surgically sterile, or are not
             refraining from sexual activity while not using adequate contraception.

          -  Require medications with a narrow therapeutic window, are receiving any
             investigational medications, or have participated in a trial with investigational
             medications within the last 30 days

          -  Have ever participated in a study with an amyloid targeting agent

          -  Have had a radiopharmaceutical imaging or treatment procedure within 7 days of the
             imaging, other than as defined in the protocol