Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.

Avid Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease; Frontotemporal Dementia

Treatments: Drug: florbetapir 18F; Drug: 18F-FDG

Study type: Interventional

Funder types: Industry

Identifiers

NCT01890343

18F-AV-45-010

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

34 participants in 3 patient groups

Frontotemporal Disorder

Experimental group

Description:

Subjects with frontotemporal disorder (FTD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F and a one-time IV bolus injection of 185 MBq of 18F-FDG.

Treatment:

Drug: 18F-FDG

Drug: florbetapir 18F

Cognitively Normal

Experimental group

Description:

Cognitively normal (CN) subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.

Treatment:

Drug: florbetapir 18F

Alzheimer's Disease

Experimental group

Description:

Subjects with Alzheimer's disease (AD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.

Treatment:

Drug: florbetapir 18F