Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain - Full Text View

Sponsor:	Avid Radiopharmaceuticals
Information provided by (Responsible Party):	Avid Radiopharmaceuticals ( Avid Radiopharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00857415

Purpose

The study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid burden assessed by histology at autopsy.

There will be two primary analyses:

The first primary analysis will evaluate the correlation between the blinded readers' rating of amyloid burden on the PET scan and the cortical amyloid burden at autopsy.
The second primary analysis will evaluate the specificity of the blinded readers' rating of presence or absence of amyloid burden on the PET scan

Condition	Intervention	Phase
Alzheimer's Disease	Drug: florbetapir F 18	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	A Phase III Study of the Correlation Between Florbetapir F 18 (18F-AV-45) PET Imaging and Amyloid Pathology

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:

Blinded read of florbetapir F 18 PET images [ Time Frame: ~12 months, following enrollment of all subjects ] [ Designated as safety issue: No ]

Enrollment:	152
Study Start Date:	December 2008
Study Completion Date:	May 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Autopsy population Those individuals with end-of-life illnesses who undergo 18F-AV-45 PET brain amyloid imaging.	Drug: florbetapir F 18 Single i.v. bolus injection of 10 mCi (370MBq) 18F-AV-45 (florbetapir F 18) Other Names: 18F-AV-45 florbetapir F 18 AV-45

Detailed Description:

For the autopsy population, approximately 150 subjects will be enrolled from various end-of-life (e.g. hospice / hospital / nursing home) and late-life (longitudinal studies of aging) populations. Enrollment will include subjects with various levels of cognitive status, ranging from cognitively normal through dementia. It is expected that amyloid burden in this elderly population will range from very low (normal aging) through moderate (e.g. cognitively normal subjects with asymptomatic amyloid deposits or MCI subjects with intermediate levels of amyloid deposits) to very high (subjects with AD).

Screening assessments may take place over several days and will include collection of demographic information, diagnostic interview, and safety assessments. At the time of screening, subjects or caregivers will be asked to provide consent for brain donation if they are not already enrolled in a brain donation program affiliated with this study, in addition to providing informed consent for the screening and imaging procedures in the study.

Subjects who qualify for the study will have a catheter placed for intravenous (i.v.) administration of florbetapir F 18. Subjects will receive a single i.v. bolus of 370 MBq (10 mCi) of florbetapir F 18 followed by brain PET imaging for 10 minutes duration, beginning approximately 50 minutes post-injection. Vital signs and safety labs will be obtained prior to the administration of florbetapir F 18 and at the completion of the imaging session. Adverse events will be continuously monitored during the imaging session. Subjects who experience an adverse event will not be discharged until the event has been resolved or stabilized.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Are males or females ≥18 years of age;
Have a projected life expectancy of ≤ 6 months as determined by the principal investigator (e.g. terminal medical condition) or are already enrolled in a longitudinal study of aging with an autopsy component;
Can tolerate a 10 minute PET scan; and
Give informed consent for study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die.

Exclusion Criteria:

Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;
Have any major, focal structural loss of brain matter;
Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);
Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);
Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);
Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
Are females of childbearing potential who are pregnant or not using adequate contraception.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857415

Locations

United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Sun Health Research Institute
Sun City, Arizona, United States, 85372
United States, California
U of California, Irvine Medical Center
Irvine, California, United States, 92868
United States, Florida
Wien Center for Alzhiemer's Disease and Memory Disorders
Miami Beach, Florida, United States, 33140
United States, New York
Neurological Associates of Albany P.C.
Albany, New York, United States, 12208
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Kettering Medical Center
Kettering, Ohio, United States, 45429

Sponsors and Collaborators

Avid Radiopharmaceuticals

More Information

No publications provided

Responsible Party:	Avid Radiopharmaceuticals ( Avid Radiopharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00857415 History of Changes
Other Study ID Numbers:	18F-AV-45-A07
Study First Received:	March 5, 2009
Last Updated:	November 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avid Radiopharmaceuticals:

florbetapir F 18 PET
amyloid imaging
Amyloid pathology in the brain

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 02, 2012