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

Study Overview
=================
Brief 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).

Official Title
-----------------
A Study Evaluating the Imaging Characteristics of Florbetapir 18F (18F-AV-45) in Patients With Frontotemporal Dementia Compared to Patients With Alzheimer's Disease and Normal Controls.

Conditions
-----------------
Alzheimer's Disease, Frontotemporal Dementia

Intervention / Treatment
-----------------
* Drug: florbetapir 18F
* Drug: 18F-FDG


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frontotemporal Disorder<br>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. | Drug: florbetapir 18F<br>* Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.<br>* Other names: Amyvid;Drug: 18F-FDG<br>* FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.<br>* Other names: fludeoxyglucose (18F);|
| Experimental: Cognitively Normal<br>Cognitively normal (CN) subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. | Drug: florbetapir 18F<br>* Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.<br>* Other names: Amyvid;|
| Experimental: Alzheimer's Disease<br>Subjects with Alzheimer's disease (AD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. | Drug: florbetapir 18F<br>* Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.<br>* Other names: Amyvid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Amyloid Image Assessment | Four readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied. | 50-60 min after injection | 
| Quantitative Amyloid Image Assessment | The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr). | 50-60 minutes after injection |