Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.
Primary Purpose
Alzheimer's Disease, Frontotemporal Dementia
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
florbetapir 18F
18F-FDG
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease
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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Frontotemporal Disorder
Cognitively Normal
Alzheimer's Disease
Arm 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.
Cognitively normal (CN) subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Subjects with Alzheimer's disease (AD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01890343
First Posted
June 27, 2013
Last Updated
September 16, 2014
Sponsor
Avid Radiopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01890343
Brief Title
Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Frontotemporal Dementia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Frontotemporal Disorder
Arm Type
Experimental
Arm 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.
Arm Title
Cognitively Normal
Arm Type
Experimental
Arm Description
Cognitively normal (CN) subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Arm Title
Alzheimer's Disease
Arm Type
Experimental
Arm Description
Subjects with Alzheimer's disease (AD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Intervention Type
Drug
Intervention Name(s)
florbetapir 18F
Other Intervention Name(s)
Florbetapir F 18, 18F-AV-45, Amyvid
Intervention Description
Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Intervention Type
Drug
Intervention Name(s)
18F-FDG
Other Intervention Name(s)
FDG, fluorodeoxyglucose (18F), fludeoxyglucose (18F)
Intervention Description
FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.
Primary Outcome Measure Information:
Title
Qualitative Amyloid Image Assessment
Description
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.
Time Frame
50-60 min after injection
Title
Quantitative Amyloid Image Assessment
Description
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).
Time Frame
50-60 minutes after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 3LJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.
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